Demo logical data model
1.0.0 - STU1
Demo logical data model
1.0.0 - STU1
Demo logical data model, published by My Organization. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/wgroup6/11615 and changes regularly. See the Directory of published versions
| Active as of 2023-10-31 |
XML representation of the MedicinalProduct logical model.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="MedicinalProduct"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the the element can appear in the instance">Card.</a></th><th style="width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description & Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct" title="ISO 11615 Authorised Medicinal Product">MedicinalProduct</a><a name="MedicinalProduct"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://build.fhir.org/types.html#Base">Base</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-weight:bold">Instances of this logical model are not marked to be the target of a Reference</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MPID" title="This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2)">MPID</a><a name="MedicinalProduct.MPID"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.CombinedPharmaceuticalDoseForm" title="The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3)">CombinedPharmaceuticalDoseForm</a><a name="MedicinalProduct.CombinedPharmaceuticalDoseForm"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.AdditionalMonitoringIndicator" title="If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4)">AdditionalMonitoringIndicator</a><a name="MedicinalProduct.AdditionalMonitoringIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.SpecialMeasures" title="If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5)">SpecialMeasures</a><a name="MedicinalProduct.SpecialMeasures"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PaediatricUseIndicator" title="This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6)">PaediatricUseIndicator</a><a name="MedicinalProduct.PaediatricUseIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.OrphanDesignationStatus" title="The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7)">OrphanDesignationStatus</a><a name="MedicinalProduct.OrphanDesignationStatus"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.AttachedDocument" title="9.2.2.11">AttachedDocument</a><a name="MedicinalProduct.AttachedDocument"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.2.2.11<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.AttachedDocument.Identifier" title="The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)">Identifier</a><a name="MedicinalProduct.AttachedDocument.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.AttachedDocument.EffectiveDate" title="The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)">EffectiveDate</a><a name="MedicinalProduct.AttachedDocument.EffectiveDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.AttachedDocument.Type" title="The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)">Type</a><a name="MedicinalProduct.AttachedDocument.Type"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.AttachedDocument.Content" title="The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)">Content</a><a name="MedicinalProduct.AttachedDocument.Content"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ED.html" title="Element">ED</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.AttachedDocument.Language" title="This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)">Language</a><a name="MedicinalProduct.AttachedDocument.Language"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.AttachedDocument.MediaType" title="This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)">MediaType</a><a name="MedicinalProduct.AttachedDocument.MediaType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.AttachedDocument.VersionNumber" title="This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)">VersionNumber</a><a name="MedicinalProduct.AttachedDocument.VersionNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.AttachedDocument.VersionSetIdentifier" title="This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)">VersionSetIdentifier</a><a name="MedicinalProduct.AttachedDocument.VersionSetIdentifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication" title="9.9.2.3">Contraindication</a><a name="MedicinalProduct.Contraindication"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.ContraindicationsText" title="The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)">ContraindicationsText</a><a name="MedicinalProduct.Contraindication.ContraindicationsText"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure" title="The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)">ContraindicationsAsDisease-Symptom-Procedure</a><a name="MedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.DiseaseStatus" title="The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)">DiseaseStatus</a><a name="MedicinalProduct.Contraindication.DiseaseStatus"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.Comorbidity" title="The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)">Comorbidity</a><a name="MedicinalProduct.Contraindication.Comorbidity"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.OtherTherapySpecifics" title="9.9.2.6">OtherTherapySpecifics</a><a name="MedicinalProduct.Contraindication.OtherTherapySpecifics"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.6<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType" title="The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)">TherapyRelationshipType</a><a name="MedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.OtherTherapySpecifics.Medication" title="Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)">Medication</a><a name="MedicinalProduct.Contraindication.OtherTherapySpecifics.Medication"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.PopulationSpecifics" title="9.9.2.5">PopulationSpecifics</a><a name="MedicinalProduct.Contraindication.PopulationSpecifics"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.5<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.PopulationSpecifics.Age" title="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)">Age</a><a name="MedicinalProduct.Contraindication.PopulationSpecifics.Age"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow" title="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)">AgeRangeLow</a><a name="MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh" title="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)">AgeRangeHigh</a><a name="MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.PopulationSpecifics.Gender" title="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)">Gender</a><a name="MedicinalProduct.Contraindication.PopulationSpecifics.Gender"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.PopulationSpecifics.Race" title="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)">Race</a><a name="MedicinalProduct.Contraindication.PopulationSpecifics.Race"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition" title="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)">PhysiologicalCondition</a><a name="MedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication" title="9.9.2.2">TherapeuticIndication</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.IndicationText" title="The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)">IndicationText</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.IndicationText"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure" title="The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)">IndicationAsDisease-Symptom-Procedure</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus" title="The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)">DiseaseStatus</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity" title="If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)">Comorbidity</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect" title="The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)">IntendedEffect</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration" title="If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)">Timing-Duration</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics" title="9.9.2.6">OtherTherapySpecifics</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.6<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType" title="The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)">TherapyRelationshipType</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication" title="Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)">Medication</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics" title="9.9.2.5">PopulationSpecifics</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.5<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age" title="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)">Age</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeLow" title="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)">AgeRangeLow</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeLow"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh" title="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)">AgeRangeHigh</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender" title="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)">Gender</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race" title="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)">Race</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition" title="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)">PhysiologicalCondition</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects" title="9.9.2.4">UndesirableEffects</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText" title="The text of the undesirable effect shall be given. (9.9.2.4.2)">UndesirableEffectText</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The text of the undesirable effect shall be given. (9.9.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect" title="The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)">UndesirableEffectAsSymptom-Condition-Effect</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification" title="The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)">Symptom-Condition-EffectClassification</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence" title="The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)">FrequencyOfOccurrence</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics" title="9.9.2.5">PopulationSpecifics</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.5<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age" title="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)">Age</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow" title="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)">AgeRangeLow</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh" title="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)">AgeRangeHigh</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender" title="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)">Gender</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race" title="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)">Race</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition" title="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)">PhysiologicalCondition</a><a name="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Header" title="9.2.2.10">Header</a><a name="MedicinalProduct.Header"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.2.2.10</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Header.Identifier" title="This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)">Identifier</a><a name="MedicinalProduct.Header.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Header.EffectiveDate" title="The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)">EffectiveDate</a><a name="MedicinalProduct.Header.EffectiveDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Header.Language" title="This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)">Language</a><a name="MedicinalProduct.Header.Language"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Header.VersionNumber" title="This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)">VersionNumber</a><a name="MedicinalProduct.Header.VersionNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Header.VersionSetIdentifier" title="This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)">VersionSetIdentifier</a><a name="MedicinalProduct.Header.VersionSetIdentifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Interactions" title="9.9.2.7">Interactions</a><a name="MedicinalProduct.Interactions"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.7<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Interactions.InteractionsText" title="The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)">InteractionsText</a><a name="MedicinalProduct.Interactions.InteractionsText"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Interactions.Interactant" title="This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)">Interactant</a><a name="MedicinalProduct.Interactions.Interactant"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Interactions.InteractionsType" title="The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)">InteractionsType</a><a name="MedicinalProduct.Interactions.InteractionsType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Interactions.InteractionsEffect" title="The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)">InteractionsEffect</a><a name="MedicinalProduct.Interactions.InteractionsEffect"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Interactions.InteractionsIncidence" title="The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)">InteractionsIncidence</a><a name="MedicinalProduct.Interactions.InteractionsIncidence"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Interactions.ManagementActions" title="The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)">ManagementActions</a><a name="MedicinalProduct.Interactions.ManagementActions"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation" title="9.5.2.2">Manufacturer-Establishment_Organisation</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation" title="9.5.2.3">Manufacturing-BusinessOperation</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType" title="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)">OperationType</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber" title="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)">ManufacturingAuthorisationReferenceNumber</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate" title="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)">EffectiveDate</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator" title="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation" title="9.3.2.5">MedicinesRegulatoryAgency_Organisation</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.5</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation" title="9.3.2.2">MarketingAuthorisation</a><a name="MedicinalProduct.MarketingAuthorisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.2</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber" title="The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)">MarketingAuthorisationNumber</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.Country" title="The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)">Country</a><a name="MedicinalProduct.MarketingAuthorisation.Country"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply" title="The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)">LegalStatusOfSupply</a><a name="MedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.AuthorisationStatus" title="The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)">AuthorisationStatus</a><a name="MedicinalProduct.MarketingAuthorisation.AuthorisationStatus"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate" title="The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)">AuthorisationStatusDate</a><a name="MedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.ValidityPeriodStart" title="The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)">ValidityPeriodStart</a><a name="MedicinalProduct.MarketingAuthorisation.ValidityPeriodStart"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd" title="The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)">ValidityPeriodEnd</a><a name="MedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate" title="The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)">DataExclusivityStartDate</a><a name="MedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate" title="The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)">DataExclusivityEndDate</a><a name="MedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation" title="The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)">DateOfFirstAuthorisation</a><a name="MedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.InternationalBirthDate" title="This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)">InternationalBirthDate</a><a name="MedicinalProduct.MarketingAuthorisation.InternationalBirthDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation" title="9.3.2.10">JurisdictionalMarketingAuthorisation</a><a name="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.10<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country" title="This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)">Country</a><a name="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction" title="This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)">Jurisdiction</a><a name="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber" title="The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)">MarketingAuthorisationNumber</a><a name="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply" title="The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)">LegalStatusOfSupply</a><a name="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation" title="9.3.2.3">MarketingAuthorisationHolder_Organisation</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.3</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME" title="9.3.2.4">SME</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.4</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMEFlag" title="This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)">SMEFlag</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMEFlag"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-BL.html" title="Element">BL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.Size" title="The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)">Size</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.Size"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMENumber" title="This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)">SMENumber</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMENumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.StatusDate" title="This is the date when the SME status was granted. (9.3.2.4.4)">StatusDate</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.StatusDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is the date when the SME status was granted. (9.3.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure" title="9.3.2.6">MarketingAuthorisationProcedure</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.6</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number" title="The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)">ProcedureIdentifier-Number</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType" title="The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)">ProcedureType</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart" title="The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)">ProcedureDateStart</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd" title="The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)">ProcedureDateEnd</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication" title="9.3.2.7">MarketingAuthorisationApplication</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.7<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number" title="A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)">ApplicationIdentifier-Number</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType" title="The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)">ApplicationType</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate" title="The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)">ApplicationDate</a><a name="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation" title="9.3.2.5">MedicinesRegulatoryAgency_Organisation</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.5</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.StatusReasons" title="9.3.2.9">StatusReasons</a><a name="MedicinalProduct.MarketingAuthorisation.StatusReasons"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.9</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.StatusReasons.Reason" title="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)">Reason</a><a name="MedicinalProduct.MarketingAuthorisation.StatusReasons.Reason"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment" title="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)">ReasonComment</a><a name="MedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds" title="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)">LegalGrounds</a><a name="MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment" title="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)">LegalGroundsComment</a><a name="MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate" title="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)">RestoreDate</a><a name="MedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore" title="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)">ConditionToRestore</a><a name="MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment" title="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)">ConditionToRestoreComment</a><a name="MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType" title="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)">ChangeRequestOrganisationType</a><a name="MedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken" title="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)">GeographicAreaForActionTaken</a><a name="MedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus" title="9.3.2.8">MarketingStatus</a><a name="MedicinalProduct.MarketingStatus"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.8<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.Country" title="The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)">Country</a><a name="MedicinalProduct.MarketingStatus.Country"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.Jurisdiction" title="Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)">Jurisdiction</a><a name="MedicinalProduct.MarketingStatus.Jurisdiction"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.MarketingStatus" title="This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)">MarketingStatus</a><a name="MedicinalProduct.MarketingStatus.MarketingStatus"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.MarketingDateStart" title="The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)">MarketingDateStart</a><a name="MedicinalProduct.MarketingStatus.MarketingDateStart"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.MarketingDateStop" title="The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)">MarketingDateStop</a><a name="MedicinalProduct.MarketingStatus.MarketingDateStop"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.RiskOfSupplyShortage" title="Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)">RiskOfSupplyShortage</a><a name="MedicinalProduct.MarketingStatus.RiskOfSupplyShortage"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-BL.html" title="Element">BL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment" title="Any additional comment on supply shortage. (9.3.2.8.8)">RiskOfSupplyShortageComment</a><a name="MedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Any additional comment on supply shortage. (9.3.2.8.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.StatusReasons" title="9.3.2.9">StatusReasons</a><a name="MedicinalProduct.MarketingStatus.StatusReasons"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.9</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.StatusReasons.Reason" title="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)">Reason</a><a name="MedicinalProduct.MarketingStatus.StatusReasons.Reason"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.StatusReasons.ReasonComment" title="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)">ReasonComment</a><a name="MedicinalProduct.MarketingStatus.StatusReasons.ReasonComment"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds" title="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)">LegalGrounds</a><a name="MedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment" title="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)">LegalGroundsComment</a><a name="MedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.StatusReasons.RestoreDate" title="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)">RestoreDate</a><a name="MedicinalProduct.MarketingStatus.StatusReasons.RestoreDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore" title="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)">ConditionToRestore</a><a name="MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment" title="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)">ConditionToRestoreComment</a><a name="MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType" title="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)">ChangeRequestOrganisationType</a><a name="MedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken" title="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)">GeographicAreaForActionTaken</a><a name="MedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile" title="9.2.2.5">MasterFile</a><a name="MedicinalProduct.MasterFile"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.2.2.5<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.FileType" title="This attribute is to define which kind of master file is indicated (9.2.2.5.2)">FileType</a><a name="MedicinalProduct.MasterFile.FileType"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute is to define which kind of master file is indicated (9.2.2.5.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.FileCode" title="This attribute is for a code to uniquely identify a master file. (9.2.2.5.3)">FileCode</a><a name="MedicinalProduct.MasterFile.FileCode"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute is for a code to uniquely identify a master file. (9.2.2.5.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation" title="9.2.2.6">MasterFileHolder_Organisation</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.2.2.6</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName" title="9.2.2.8">MedicinalProductName</a><a name="MedicinalProduct.MedicinalProductName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.2.2.8<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.FullName" title="The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2)">FullName</a><a name="MedicinalProduct.MedicinalProductName.FullName"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.InventedNamePart" title="The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)">InventedNamePart</a><a name="MedicinalProduct.MedicinalProductName.InventedNamePart"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.ScientificNamePart" title="The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)">ScientificNamePart</a><a name="MedicinalProduct.MedicinalProductName.ScientificNamePart"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.StrengthPart" title="The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)">StrengthPart</a><a name="MedicinalProduct.MedicinalProductName.StrengthPart"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.PharmaceuticalDoseFormPart" title="The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)">PharmaceuticalDoseFormPart</a><a name="MedicinalProduct.MedicinalProductName.PharmaceuticalDoseFormPart"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.FormulationPart" title="The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)">FormulationPart</a><a name="MedicinalProduct.MedicinalProductName.FormulationPart"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.IntendedUsePart" title="The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)">IntendedUsePart</a><a name="MedicinalProduct.MedicinalProductName.IntendedUsePart"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.TargetPopulationPart" title="The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)">TargetPopulationPart</a><a name="MedicinalProduct.MedicinalProductName.TargetPopulationPart"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.ContainerOrPackPart" title="The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)">ContainerOrPackPart</a><a name="MedicinalProduct.MedicinalProductName.ContainerOrPackPart"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.DevicePart" title="The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)">DevicePart</a><a name="MedicinalProduct.MedicinalProductName.DevicePart"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.TrademarkOrCompanyNamePart" title="The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)">TrademarkOrCompanyNamePart</a><a name="MedicinalProduct.MedicinalProductName.TrademarkOrCompanyNamePart"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.Time-PeriodPart" title="The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)">Time-PeriodPart</a><a name="MedicinalProduct.MedicinalProductName.Time-PeriodPart"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.FlavourPart" title="The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)">FlavourPart</a><a name="MedicinalProduct.MedicinalProductName.FlavourPart"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.DelimiterPart" title="A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)">DelimiterPart</a><a name="MedicinalProduct.MedicinalProductName.DelimiterPart"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.Country-Language" title="9.2.2.9">Country-Language</a><a name="MedicinalProduct.MedicinalProductName.Country-Language"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.2.2.9<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.Country-Language.Country" title="The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)">Country</a><a name="MedicinalProduct.MedicinalProductName.Country-Language.Country"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.Country-Language.Jurisdiction" title="The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)">Jurisdiction</a><a name="MedicinalProduct.MedicinalProductName.Country-Language.Jurisdiction"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.MedicinalProductName.Country-Language.Language" title="The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)">Language</a><a name="MedicinalProduct.MedicinalProductName.Country-Language.Language"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.OrphanDesignation" title="9.2.2.3">OrphanDesignation</a><a name="MedicinalProduct.OrphanDesignation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.2.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.OrphanDesignation.OrphanIndicationType" title="This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)">OrphanIndicationType</a><a name="MedicinalProduct.OrphanDesignation.OrphanIndicationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.OrphanDesignation.OrphanProcedureNumber" title="This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)">OrphanProcedureNumber</a><a name="MedicinalProduct.OrphanDesignation.OrphanProcedureNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus" title="This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)">OrphanDesignationAuthorisationStatus</a><a name="MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate" title="This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)">OrphanDesignationAuthorisationDate</a><a name="MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.OrphanDesignation.OrphanDesignationNumber" title="This field is to indicate the orphan designation decision number. (9.2.2.3.6)">OrphanDesignationNumber</a><a name="MedicinalProduct.OrphanDesignation.OrphanDesignationNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This field is to indicate the orphan designation decision number. (9.2.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct" title="9.6.2.2">PackagedMedicinalProduct</a><a name="MedicinalProduct.PackagedMedicinalProduct"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PCID" title="This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)">PCID</a><a name="MedicinalProduct.PackagedMedicinalProduct.PCID"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageDescription" title="A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)">PackageDescription</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageDescription"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier" title="9.6.2.8">BatchIdentifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.8<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID1" title="The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)">BAID1</a><a name="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID1"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID2" title="The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)">BAID2</a><a name="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.ExpirationDate" title="This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)">ExpirationDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.ExpirationDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation" title="9.5.2.2">Manufacturer-Establishment_Organisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation" title="9.5.2.3">Manufacturing-BusinessOperation</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType" title="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)">OperationType</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber" title="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)">ManufacturingAuthorisationReferenceNumber</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate" title="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)">EffectiveDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator" title="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation" title="9.3.2.5">MedicinesRegulatoryAgency_Organisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.5</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation" title="9.3.2.2">MarketingAuthorisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.2</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber" title="The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)">MarketingAuthorisationNumber</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.Country" title="The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)">Country</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.Country"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply" title="The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)">LegalStatusOfSupply</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatus" title="The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)">AuthorisationStatus</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatus"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate" title="The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)">AuthorisationStatusDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodStart" title="The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)">ValidityPeriodStart</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodStart"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd" title="The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)">ValidityPeriodEnd</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate" title="The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)">DataExclusivityStartDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate" title="The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)">DataExclusivityEndDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation" title="The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)">DateOfFirstAuthorisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.InternationalBirthDate" title="This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)">InternationalBirthDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.InternationalBirthDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation" title="9.3.2.10">JurisdictionalMarketingAuthorisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.10<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country" title="This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)">Country</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction" title="This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)">Jurisdiction</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber" title="The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)">MarketingAuthorisationNumber</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply" title="The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)">LegalStatusOfSupply</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation" title="9.3.2.3">MarketingAuthorisationHolder_Organisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.3</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME" title="9.3.2.4">SME</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.4</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMEFlag" title="This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)">SMEFlag</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMEFlag"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-BL.html" title="Element">BL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.Size" title="The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)">Size</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.Size"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMENumber" title="This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)">SMENumber</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMENumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.StatusDate" title="This is the date when the SME status was granted. (9.3.2.4.4)">StatusDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.StatusDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is the date when the SME status was granted. (9.3.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure" title="9.3.2.6">MarketingAuthorisationProcedure</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.6</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number" title="The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)">ProcedureIdentifier-Number</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType" title="The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)">ProcedureType</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart" title="The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)">ProcedureDateStart</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd" title="The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)">ProcedureDateEnd</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication" title="9.3.2.7">MarketingAuthorisationApplication</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.7<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number" title="A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)">ApplicationIdentifier-Number</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType" title="The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)">ApplicationType</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate" title="The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)">ApplicationDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation" title="9.3.2.5">MedicinesRegulatoryAgency_Organisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.5</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons" title="9.3.2.9">StatusReasons</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.9</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.Reason" title="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)">Reason</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.Reason"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment" title="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)">ReasonComment</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds" title="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)">LegalGrounds</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment" title="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)">LegalGroundsComment</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate" title="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)">RestoreDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore" title="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)">ConditionToRestore</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment" title="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)">ConditionToRestoreComment</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType" title="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)">ChangeRequestOrganisationType</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken" title="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)">GeographicAreaForActionTaken</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus" title="9.3.2.8">MarketingStatus</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.8<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Country" title="The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)">Country</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Country"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Jurisdiction" title="Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)">Jurisdiction</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Jurisdiction"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingStatus" title="This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)">MarketingStatus</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingStatus"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStart" title="The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)">MarketingDateStart</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStart"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStop" title="The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)">MarketingDateStop</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStop"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortage" title="Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)">RiskOfSupplyShortage</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortage"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-BL.html" title="Element">BL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment" title="Any additional comment on supply shortage. (9.3.2.8.8)">RiskOfSupplyShortageComment</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Any additional comment on supply shortage. (9.3.2.8.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons" title="9.3.2.9">StatusReasons</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.9</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.Reason" title="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)">Reason</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.Reason"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ReasonComment" title="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)">ReasonComment</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ReasonComment"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds" title="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)">LegalGrounds</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment" title="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)">LegalGroundsComment</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.RestoreDate" title="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)">RestoreDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.RestoreDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore" title="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)">ConditionToRestore</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment" title="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)">ConditionToRestoreComment</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType" title="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)">ChangeRequestOrganisationType</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken" title="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)">GeographicAreaForActionTaken</a><a name="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container" title="9.6.2.3">PackageItem_Container</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerType" title="The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)">PackageItem_ContainerType</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PackageItem_ContainerType"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerQuantity" title="The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)">PackageItem_ContainerQuantity</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PackageItem_ContainerQuantity"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Material" title="The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)">Material</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Material"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.AlternateMaterial" title="The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)">AlternateMaterial</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.AlternateMaterial"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier" title="9.6.2.4">DataCarrierIdentifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.CodeSystem" title="The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)">CodeSystem</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier.CodeSystem"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.Value" title="The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)">Value</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier.Value"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device" title="9.6.2.12">Device</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.12<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceType" title="The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)">DeviceType</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceType"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceTradeName" title="This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)">DeviceTradeName</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceTradeName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceQuantity" title="The quantity of the device present in the pack shall be specified. (9.6.2.12.4)">DeviceQuantity</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceQuantity"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The quantity of the device present in the pack shall be specified. (9.6.2.12.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceListingNumber" title="This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)">DeviceListingNumber</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceListingNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceIdentifier" title="A unique device identifier needs to be specified. (9.6.2.12.6)">DeviceIdentifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceIdentifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">A unique device identifier needs to be specified. (9.6.2.12.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ModelNumber" title="This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)">ModelNumber</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ModelNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.SterilityIndicator" title="Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)">SterilityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.SterilityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.SterilisationRequirementIndicator" title="Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)">SterilisationRequirementIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.SterilisationRequirementIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceUsage" title="The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)">DeviceUsage</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceUsage"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier" title="9.6.2.15">DeviceBatchIdentifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.15<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.BatchNumber" title="Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)">BatchNumber</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier.BatchNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.ExpirationDate" title="Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)">ExpirationDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier.ExpirationDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial" title="9.6.2.13">DeviceMaterial</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.13<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Substance" title="The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)">Substance</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.Substance"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Alternate" title="This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)">Alternate</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.Alternate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-BL.html" title="Element">BL</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.AllergenicIndicator" title="This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)">AllergenicIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.AllergenicIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-BL.html" title="Element">BL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature" title="9.6.2.14">DeviceNomenclature</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.14<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.CodeSystem" title="The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)">CodeSystem</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature.CodeSystem"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.Value" title="The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)">Value</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature.Value"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation" title="9.5.2.2">Manufacturer-Establishment_Organisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation" title="9.5.2.3">Manufacturing-BusinessOperation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType" title="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)">OperationType</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber" title="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)">ManufacturingAuthorisationReferenceNumber</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate" title="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)">EffectiveDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator" title="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation" title="9.3.2.5">MedicinesRegulatoryAgency_Organisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.5</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics" title="9.6.2.22">OtherCharacteristics</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.22<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.CodeSystem" title="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)">CodeSystem</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics.CodeSystem"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.Value" title="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)">Value</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics.Value"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics" title="9.6.2.21">PhysicalCharacteristics</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.21</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Height" title="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)">Height</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Height"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Width" title="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)">Width</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Width"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Depth" title="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)">Depth</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Depth"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Weight" title="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)">Weight</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Weight"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.NominalVolume" title="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)">NominalVolume</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.NominalVolume"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.ExternalDiameter" title="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)">ExternalDiameter</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.ExternalDiameter"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Shape" title="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)">Shape</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Shape"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Colour" title="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)">Colour</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Colour"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Imprint" title="Where applicable, the imprint can be specified as text. (9.6.2.21.10)">Imprint</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Imprint"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the imprint can be specified as text. (9.6.2.21.10)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Image" title="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)">Image</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Image"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ED.html" title="Element">ED</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Scoring" title="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)">Scoring</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Scoring"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage" title="9.6.2.11">ShelfLife-Storage</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.11<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeType" title="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)">ShelfLifeType</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.ShelfLifeType"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod" title="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)">ShelfLifeTimePeriod</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage" title="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)">SpecialPrecautionsForStorage</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem" title="9.6.2.20">ManufacturedItem</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.20<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedDoseForm" title="This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)">ManufacturedDoseForm</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.ManufacturedDoseForm"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.UnitOfPresentation" title="This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)">UnitOfPresentation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.UnitOfPresentation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedItemQuantity" title="The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)">ManufacturedItemQuantity</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.ManufacturedItemQuantity"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient" title="9.7.2.2">Ingredient</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.7.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.IngredientRole" title="The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)">IngredientRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.IngredientRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.AllergenicIndicator" title="This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)">AllergenicIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.AllergenicIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-BL.html" title="Element">BL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation" title="9.5.2.2">Manufacturer-Establishment_Organisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation" title="9.5.2.3">Manufacturing-BusinessOperation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType" title="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)">OperationType</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber" title="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)">ManufacturingAuthorisationReferenceNumber</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate" title="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)">EffectiveDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator" title="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation" title="9.3.2.5">MedicinesRegulatoryAgency_Organisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.5</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance" title="9.7.2.4">SpecifiedSubstance</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.7.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance" title="When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)">SpecifiedSubstance</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup" title="The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)">SpecifiedSubstanceGroup</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator" title="The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength" title="9.7.2.5">Strength</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.7.2.5<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation" title="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)">Strength_Presentation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength_Presentation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-RTO.html" title="Element">RTO</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration" title="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)">Strength_Concentration</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength_Concentration"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-RTO.html" title="Element">RTO</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint" title="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)">MeasurementPoint</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country" title="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)">Country</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength" title="9.7.2.6">ReferenceStrength</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.7.2.6<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance" title="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)">ReferenceSubstance</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance" title="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)">ReferenceSpecifiedSubstance</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength" title="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)">ReferenceStrength</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-RTO.html" title="Element">RTO</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint" title="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)">ReferenceStrengthMeasurementPoint</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry" title="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)">ReferenceStrengthCountry</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance" title="9.7.2.3">Substance</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.7.2.3</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Substance" title="A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)">Substance</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Substance"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength" title="9.7.2.5">Strength</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.7.2.5<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Presentation" title="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)">Strength_Presentation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.Strength_Presentation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-RTO.html" title="Element">RTO</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Concentration" title="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)">Strength_Concentration</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.Strength_Concentration"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-RTO.html" title="Element">RTO</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint" title="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)">MeasurementPoint</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Country" title="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)">Country</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.Country"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength" title="9.7.2.6">ReferenceStrength</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.7.2.6<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance" title="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)">ReferenceSubstance</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance" title="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)">ReferenceSpecifiedSubstance</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength" title="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)">ReferenceStrength</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-RTO.html" title="Element">RTO</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint" title="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)">ReferenceStrengthMeasurementPoint</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry" title="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)">ReferenceStrengthCountry</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation" title="9.5.2.2">Manufacturer-Establishment_Organisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation" title="9.5.2.3">Manufacturing-BusinessOperation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType" title="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)">OperationType</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber" title="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)">ManufacturingAuthorisationReferenceNumber</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate" title="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)">EffectiveDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator" title="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation" title="9.3.2.5">MedicinesRegulatoryAgency_Organisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.5</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics" title="9.6.2.22">OtherCharacteristics</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.22<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.CodeSystem" title="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)">CodeSystem</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics.CodeSystem"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.Value" title="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)">Value</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics.Value"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics" title="9.6.2.21">PhysicalCharacteristics</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.21</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Height" title="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)">Height</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Height"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Width" title="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)">Width</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Width"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Depth" title="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)">Depth</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Depth"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Weight" title="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)">Weight</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Weight"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume" title="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)">NominalVolume</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter" title="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)">ExternalDiameter</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Shape" title="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)">Shape</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Shape"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Colour" title="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)">Colour</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Colour"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Imprint" title="Where applicable, the imprint can be specified as text. (9.6.2.21.10)">Imprint</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Imprint"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the imprint can be specified as text. (9.6.2.21.10)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Image" title="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)">Image</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Image"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ED.html" title="Element">ED</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Scoring" title="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)">Scoring</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Scoring"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation" title="9.5.2.2">Manufacturer-Establishment_Organisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation" title="9.5.2.3">Manufacturing-BusinessOperation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType" title="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)">OperationType</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber" title="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)">ManufacturingAuthorisationReferenceNumber</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate" title="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)">EffectiveDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator" title="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation" title="9.3.2.5">MedicinesRegulatoryAgency_Organisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.5</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics" title="9.6.2.22">OtherCharacteristics</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.22<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.CodeSystem" title="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)">CodeSystem</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics.CodeSystem"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.Value" title="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)">Value</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics.Value"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component" title="9.6.2.9">Package_Component</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.9<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentType" title="The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)">ComponentType</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.ComponentType"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentMaterial" title="The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)">ComponentMaterial</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.ComponentMaterial"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentAlternateMaterial" title="Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)">ComponentAlternateMaterial</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.ComponentAlternateMaterial"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation" title="9.5.2.2">Manufacturer-Establishment_Organisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation" title="9.5.2.3">Manufacturing-BusinessOperation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType" title="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)">OperationType</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber" title="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)">ManufacturingAuthorisationReferenceNumber</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate" title="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)">EffectiveDate</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator" title="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation" title="9.3.2.5">MedicinesRegulatoryAgency_Organisation</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.5</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101100000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics" title="9.6.2.21">PhysicalCharacteristics</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.21</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Height" title="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)">Height</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Height"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Width" title="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)">Width</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Width"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Depth" title="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)">Depth</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Depth"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Weight" title="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)">Weight</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Weight"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.NominalVolume" title="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)">NominalVolume</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.NominalVolume"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.ExternalDiameter" title="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)">ExternalDiameter</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.ExternalDiameter"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Shape" title="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)">Shape</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Shape"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Colour" title="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)">Colour</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Colour"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Imprint" title="Where applicable, the imprint can be specified as text. (9.6.2.21.10)">Imprint</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Imprint"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the imprint can be specified as text. (9.6.2.21.10)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Image" title="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)">Image</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Image"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ED.html" title="Element">ED</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Scoring" title="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)">Scoring</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Scoring"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics" title="9.6.2.21">PhysicalCharacteristics</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.21</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Height" title="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)">Height</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Height"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Width" title="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)">Width</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Width"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Depth" title="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)">Depth</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Depth"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Weight" title="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)">Weight</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Weight"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.NominalVolume" title="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)">NominalVolume</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.NominalVolume"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.ExternalDiameter" title="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)">ExternalDiameter</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.ExternalDiameter"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Shape" title="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)">Shape</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Shape"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Colour" title="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)">Colour</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Colour"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Imprint" title="Where applicable, the imprint can be specified as text. (9.6.2.21.10)">Imprint</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Imprint"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the imprint can be specified as text. (9.6.2.21.10)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Image" title="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)">Image</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Image"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ED.html" title="Element">ED</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Scoring" title="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)">Scoring</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Scoring"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage" title="9.6.2.11">ShelfLife-Storage</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.11<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeType" title="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)">ShelfLifeType</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.ShelfLifeType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeTimePeriod" title="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)">ShelfLifeTimePeriod</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.ShelfLifeTimePeriod"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.SpecialPrecautionsForStorage" title="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)">SpecialPrecautionsForStorage</a><a name="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.SpecialPrecautionsForStorage"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct" title="9.8.2.2">PharmaceuticalProduct</a><a name="MedicinalProduct.PharmaceuticalProduct"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.8.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm" title="This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)">AdministrableDoseForm</a><a name="MedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.UnitOfPresentation" title="The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)">UnitOfPresentation</a><a name="MedicinalProduct.PharmaceuticalProduct.UnitOfPresentation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device" title="9.6.2.12">Device</a><a name="MedicinalProduct.PharmaceuticalProduct.Device"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.12<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceType" title="The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)">DeviceType</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceType"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName" title="This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)">DeviceTradeName</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity" title="The quantity of the device present in the pack shall be specified. (9.6.2.12.4)">DeviceQuantity</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The quantity of the device present in the pack shall be specified. (9.6.2.12.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber" title="This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)">DeviceListingNumber</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier" title="A unique device identifier needs to be specified. (9.6.2.12.6)">DeviceIdentifier</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">A unique device identifier needs to be specified. (9.6.2.12.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.ModelNumber" title="This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)">ModelNumber</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.ModelNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator" title="Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)">SterilityIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator" title="Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)">SterilisationRequirementIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage" title="The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)">DeviceUsage</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier" title="9.6.2.15">DeviceBatchIdentifier</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.15<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber" title="Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)">BatchNumber</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate" title="Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)">ExpirationDate</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial" title="9.6.2.13">DeviceMaterial</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.13<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance" title="The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)">Substance</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate" title="This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)">Alternate</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-BL.html" title="Element">BL</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator" title="This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)">AllergenicIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-BL.html" title="Element">BL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature" title="9.6.2.14">DeviceNomenclature</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.14<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem" title="The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)">CodeSystem</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value" title="The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)">Value</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation" title="9.5.2.2">Manufacturer-Establishment_Organisation</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation" title="9.5.2.3">Manufacturing-BusinessOperation</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType" title="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)">OperationType</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber" title="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)">ManufacturingAuthorisationReferenceNumber</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate" title="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)">EffectiveDate</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator" title="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation" title="9.3.2.5">MedicinesRegulatoryAgency_Organisation</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.5</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics" title="9.6.2.22">OtherCharacteristics</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.22<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem" title="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)">CodeSystem</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value" title="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)">Value</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics" title="9.6.2.21">PhysicalCharacteristics</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.21</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height" title="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)">Height</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width" title="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)">Width</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth" title="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)">Depth</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight" title="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)">Weight</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume" title="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)">NominalVolume</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter" title="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)">ExternalDiameter</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape" title="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)">Shape</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour" title="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)">Colour</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint" title="Where applicable, the imprint can be specified as text. (9.6.2.21.10)">Imprint</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the imprint can be specified as text. (9.6.2.21.10)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image" title="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)">Image</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ED.html" title="Element">ED</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring" title="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)">Scoring</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage" title="9.6.2.11">ShelfLife-Storage</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.6.2.11<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType" title="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)">ShelfLifeType</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod" title="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)">ShelfLifeTimePeriod</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage" title="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)">SpecialPrecautionsForStorage</a><a name="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient" title="9.7.2.2">Ingredient</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.7.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole" title="The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)">IngredientRole</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator" title="This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)">AllergenicIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-BL.html" title="Element">BL</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation" title="9.5.2.2">Manufacturer-Establishment_Organisation</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation" title="9.5.2.3">Manufacturing-BusinessOperation</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.5.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType" title="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)">OperationType</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber" title="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)">ManufacturingAuthorisationReferenceNumber</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate" title="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)">EffectiveDate</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-DT.html" title="Element">DT</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator" title="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation" title="9.3.2.5">MedicinesRegulatoryAgency_Organisation</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.3.2.5</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier" title="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)">Identifier</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name" title="The name of the organisation shall be provided in text. (9.4.2.2.3)">Name</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the organisation shall be provided in text. (9.4.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address" title="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)">Address</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator" title="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)">GeographicCoordinates</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact" title="9.4.2.4">Contact</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name" title="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)">Name</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PN.html" title="Element">PN</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom" title="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)">Telecom</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-TEL.html" title="Element">TEL</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role" title="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)">Role</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator" title="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)">ConfidentialityIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations" title="9.4.2.3">OtherLocations</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.4.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName" title="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)">LocationName</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress" title="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)">LocationAddress</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-AD.html" title="Element">AD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole" title="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)">LocationRole</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier" title="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)">Identifier</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates" title="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)">GeographicCoordinates</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance" title="9.7.2.4">SpecifiedSubstance</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.7.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance" title="When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)">SpecifiedSubstance</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup" title="The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)">SpecifiedSubstanceGroup</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator" title="The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)">ConfidentialityIndicator</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength" title="9.7.2.5">Strength</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.7.2.5<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation" title="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)">Strength_Presentation</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength_Presentation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-RTO.html" title="Element">RTO</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration" title="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)">Strength_Concentration</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength_Concentration"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-RTO.html" title="Element">RTO</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint" title="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)">MeasurementPoint</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country" title="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)">Country</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength" title="9.7.2.6">ReferenceStrength</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.7.2.6<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance" title="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)">ReferenceSubstance</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance" title="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)">ReferenceSpecifiedSubstance</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength" title="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)">ReferenceStrength</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-RTO.html" title="Element">RTO</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint" title="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)">ReferenceStrengthMeasurementPoint</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry" title="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)">ReferenceStrengthCountry</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance" title="9.7.2.3">Substance</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.7.2.3</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance" title="A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)">Substance</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength" title="9.7.2.5">Strength</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.7.2.5<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Presentation" title="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)">Strength_Presentation</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength_Presentation"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-RTO.html" title="Element">RTO</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Concentration" title="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)">Strength_Concentration</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength_Concentration"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-RTO.html" title="Element">RTO</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint" title="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)">MeasurementPoint</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country" title="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)">Country</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength" title="9.7.2.6">ReferenceStrength</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.7.2.6<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance" title="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)">ReferenceSubstance</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance" title="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)">ReferenceSpecifiedSubstance</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength" title="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)">ReferenceStrength</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-RTO.html" title="Element">RTO</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint" title="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)">ReferenceStrengthMeasurementPoint</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry" title="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)">ReferenceStrengthCountry</a><a name="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics" title="9.8.2.4">PharmaceuticalProductCharacteristics</a><a name="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.8.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem" title="The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)">CodeSystem</a><a name="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value" title="The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)">Value</a><a name="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status" title="The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)">Status</a><a name="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.PhPIDSet" title="9.8.2.6">PhPIDSet</a><a name="MedicinalProduct.PharmaceuticalProduct.PhPIDSet"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.8.2.6<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets" title="This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)">PhPIDIdentifierSets</a><a name="MedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration" title="9.8.2.3">RouteOfAdministration</a><a name="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.8.2.3<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.RouteOfAdministration" title="The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0)">RouteOfAdministration</a><a name="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.RouteOfAdministration"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.ProductClassification" title="9.2.2.4">ProductClassification</a><a name="MedicinalProduct.ProductClassification"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.2.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.ProductClassification.CodeSystem" title="The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)">CodeSystem</a><a name="MedicinalProduct.ProductClassification.CodeSystem"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.ProductClassification.Value" title="The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)">Value</a><a name="MedicinalProduct.ProductClassification.Value"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.ProductCross-Reference" title="9.2.2.7">ProductCross-Reference</a><a name="MedicinalProduct.ProductCross-Reference"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.2.2.7<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.ProductCross-Reference.I-MPIDCross-Reference" title="This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)">I_MPIDCross-Reference</a><a name="MedicinalProduct.ProductCross-Reference.I_MPIDCross-Reference"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-II.html" title="Element">II</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.ProductCross-Reference.ReferencedProductType" title="This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)">ReferencedProductType</a><a name="MedicinalProduct.ProductCross-Reference.ReferencedProductType"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication" title="9.9.2.2">TherapeuticIndication</a><a name="MedicinalProduct.TherapeuticIndication"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.2<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.IndicationText" title="The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)">IndicationText</a><a name="MedicinalProduct.TherapeuticIndication.IndicationText"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure" title="The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)">IndicationAsDisease-Symptom-Procedure</a><a name="MedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.DiseaseStatus" title="The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)">DiseaseStatus</a><a name="MedicinalProduct.TherapeuticIndication.DiseaseStatus"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.Comorbidity" title="If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)">Comorbidity</a><a name="MedicinalProduct.TherapeuticIndication.Comorbidity"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.IntendedEffect" title="The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)">IntendedEffect</a><a name="MedicinalProduct.TherapeuticIndication.IntendedEffect"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.Timing-Duration" title="If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)">Timing-Duration</a><a name="MedicinalProduct.TherapeuticIndication.Timing-Duration"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics" title="9.9.2.6">OtherTherapySpecifics</a><a name="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.6<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType" title="The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)">TherapyRelationshipType</a><a name="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.Medication" title="Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)">Medication</a><a name="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.Medication"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.PopulationSpecifics" title="9.9.2.5">PopulationSpecifics</a><a name="MedicinalProduct.TherapeuticIndication.PopulationSpecifics"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.5<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Age" title="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)">Age</a><a name="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Age"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeLow" title="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)">AgeRangeLow</a><a name="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeLow"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh" title="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)">AgeRangeHigh</a><a name="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Gender" title="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)">Gender</a><a name="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Gender"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Race" title="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)">Race</a><a name="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Race"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition" title="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)">PhysiologicalCondition</a><a name="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.UndesirableEffects" title="9.9.2.4">UndesirableEffects</a><a name="MedicinalProduct.TherapeuticIndication.UndesirableEffects"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectText" title="The text of the undesirable effect shall be given. (9.9.2.4.2)">UndesirableEffectText</a><a name="MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectText"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The text of the undesirable effect shall be given. (9.9.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect" title="The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)">UndesirableEffectAsSymptom-Condition-Effect</a><a name="MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification" title="The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)">Symptom-Condition-EffectClassification</a><a name="MedicinalProduct.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence" title="The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)">FrequencyOfOccurrence</a><a name="MedicinalProduct.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics" title="9.9.2.5">PopulationSpecifics</a><a name="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.5<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age" title="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)">Age</a><a name="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow" title="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)">AgeRangeLow</a><a name="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh" title="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)">AgeRangeHigh</a><a name="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender" title="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)">Gender</a><a name="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race" title="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)">Race</a><a name="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition" title="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)">PhysiologicalCondition</a><a name="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.UndesirableEffects" title="9.9.2.4">UndesirableEffects</a><a name="MedicinalProduct.UndesirableEffects"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.4<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.UndesirableEffects.UndesirableEffectText" title="The text of the undesirable effect shall be given. (9.9.2.4.2)">UndesirableEffectText</a><a name="MedicinalProduct.UndesirableEffects.UndesirableEffectText"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-ST.html" title="Element">ST</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The text of the undesirable effect shall be given. (9.9.2.4.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect" title="The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)">UndesirableEffectAsSymptom-Condition-Effect</a><a name="MedicinalProduct.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.UndesirableEffects.Symptom-Condition-EffectClassification" title="The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)">Symptom-Condition-EffectClassification</a><a name="MedicinalProduct.UndesirableEffects.Symptom-Condition-EffectClassification"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.UndesirableEffects.FrequencyOfOccurrence" title="The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)">FrequencyOfOccurrence</a><a name="MedicinalProduct.UndesirableEffects.FrequencyOfOccurrence"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.UndesirableEffects.PopulationSpecifics" title="9.9.2.5">PopulationSpecifics</a><a name="MedicinalProduct.UndesirableEffects.PopulationSpecifics"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-Class.html" title="BackboneElement">Class</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">9.9.2.5<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.UndesirableEffects.PopulationSpecifics.Age" title="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)">Age</a><a name="MedicinalProduct.UndesirableEffects.PopulationSpecifics.Age"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeLow" title="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)">AgeRangeLow</a><a name="MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeLow"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeHigh" title="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)">AgeRangeHigh</a><a name="MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeHigh"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-PQ.html" title="Element">PQ</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.UndesirableEffects.PopulationSpecifics.Gender" title="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)">Gender</a><a name="MedicinalProduct.UndesirableEffects.PopulationSpecifics.Gender"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.UndesirableEffects.PopulationSpecifics.Race" title="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)">Race</a><a name="MedicinalProduct.UndesirableEffects.PopulationSpecifics.Race"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-MedicinalProduct-definitions.html#MedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition" title="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)">PhysiologicalCondition</a><a name="MedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-CD.html" title="Element">CD</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)</td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<url
value="http://example.com/fhir/example/StructureDefinition/MedicinalProduct"/>
<version value="1.0.0"/>
<name value="IDMP11615Authorised"/>
<status value="active"/>
<date value="2023-10-31T13:23:44+00:00"/>
<publisher value="My Organization"/>
<contact>
<name value="My Organization"/>
<telecom>
<system value="url"/>
<value value="http://example.com/committees"/>
</telecom>
<telecom>
<system value="email"/>
<value value="my-group@example.com"/>
</telecom>
</contact>
<contact>
<name value="Bob Smith"/>
<telecom>
<system value="email"/>
<value value="bobsmith@example.com"/>
<use value="work"/>
</telecom>
</contact>
<description value="ISO 11615 Authorised Medicinal Product"/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<fhirVersion value="4.0.1"/>
<mapping>
<identity value="rim"/>
<uri value="http://hl7.org/v3"/>
<name value="RIM Mapping"/>
</mapping>
<kind value="logical"/>
<abstract value="false"/>
<type
value="http://example.com/fhir/example/StructureDefinition/MedicinalProduct"/>
<baseDefinition value="http://hl7.org/fhir/StructureDefinition/Base"/>
<derivation value="specialization"/>
<snapshot>
<element id="MedicinalProduct">
<path value="MedicinalProduct"/>
<definition value="ISO 11615 Authorised Medicinal Product"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Base"/>
<min value="0"/>
<max value="*"/>
</base>
<isModifier value="false"/>
</element>
<element id="MedicinalProduct.MPID">
<path value="MedicinalProduct.MPID"/>
<short
value="This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2)"/>
<definition
value="This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.MPID"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.CombinedPharmaceuticalDoseForm">
<path value="MedicinalProduct.CombinedPharmaceuticalDoseForm"/>
<short
value="The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3)"/>
<definition
value="The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.CombinedPharmaceuticalDoseForm"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.AdditionalMonitoringIndicator">
<path value="MedicinalProduct.AdditionalMonitoringIndicator"/>
<short
value="If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4)"/>
<definition
value="If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.AdditionalMonitoringIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.SpecialMeasures">
<path value="MedicinalProduct.SpecialMeasures"/>
<short
value="If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5)"/>
<definition
value="If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5)"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.SpecialMeasures"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.PaediatricUseIndicator">
<path value="MedicinalProduct.PaediatricUseIndicator"/>
<short
value="This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6)"/>
<definition
value="This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.PaediatricUseIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.OrphanDesignationStatus">
<path value="MedicinalProduct.OrphanDesignationStatus"/>
<short
value="The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7)"/>
<definition
value="The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.OrphanDesignationStatus"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument">
<path value="MedicinalProduct.AttachedDocument"/>
<short value="9.2.2.11"/>
<definition value="9.2.2.11"/>
<min value="1"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.AttachedDocument"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.AttachedDocument.id">
<path value="MedicinalProduct.AttachedDocument.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.AttachedDocument.extension">
<path value="MedicinalProduct.AttachedDocument.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.AttachedDocument.modifierExtension">
<path value="MedicinalProduct.AttachedDocument.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.AttachedDocument.Identifier">
<path value="MedicinalProduct.AttachedDocument.Identifier"/>
<short
value="The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)"/>
<definition
value="The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.AttachedDocument.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.EffectiveDate">
<path value="MedicinalProduct.AttachedDocument.EffectiveDate"/>
<short
value="The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)"/>
<definition
value="The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.AttachedDocument.EffectiveDate"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.Type">
<path value="MedicinalProduct.AttachedDocument.Type"/>
<short
value="The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)"/>
<definition
value="The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.AttachedDocument.Type"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.Content">
<path value="MedicinalProduct.AttachedDocument.Content"/>
<short
value="The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)"/>
<definition
value="The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.AttachedDocument.Content"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ED"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.Language">
<path value="MedicinalProduct.AttachedDocument.Language"/>
<short
value="This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)"/>
<definition
value="This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.AttachedDocument.Language"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.MediaType">
<path value="MedicinalProduct.AttachedDocument.MediaType"/>
<short
value="This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)"/>
<definition
value="This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.AttachedDocument.MediaType"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.VersionNumber">
<path value="MedicinalProduct.AttachedDocument.VersionNumber"/>
<short
value="This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)"/>
<definition
value="This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.AttachedDocument.VersionNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.VersionSetIdentifier">
<path value="MedicinalProduct.AttachedDocument.VersionSetIdentifier"/>
<short
value="This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)"/>
<definition
value="This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.AttachedDocument.VersionSetIdentifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication">
<path value="MedicinalProduct.Contraindication"/>
<short value="9.9.2.3"/>
<definition value="9.9.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.Contraindication"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.Contraindication.id">
<path value="MedicinalProduct.Contraindication.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.Contraindication.extension">
<path value="MedicinalProduct.Contraindication.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.Contraindication.modifierExtension">
<path value="MedicinalProduct.Contraindication.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.Contraindication.ContraindicationsText">
<path value="MedicinalProduct.Contraindication.ContraindicationsText"/>
<short
value="The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)"/>
<definition
value="The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.ContraindicationsText"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure">
<path
value="MedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure"/>
<short
value="The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)"/>
<definition
value="The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication.DiseaseStatus">
<path value="MedicinalProduct.Contraindication.DiseaseStatus"/>
<short
value="The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)"/>
<definition
value="The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.Contraindication.DiseaseStatus"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication.Comorbidity">
<path value="MedicinalProduct.Contraindication.Comorbidity"/>
<short
value="The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)"/>
<definition
value="The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.Contraindication.Comorbidity"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication.OtherTherapySpecifics">
<path value="MedicinalProduct.Contraindication.OtherTherapySpecifics"/>
<short value="9.9.2.6"/>
<definition value="9.9.2.6"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Contraindication.OtherTherapySpecifics"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.Contraindication.OtherTherapySpecifics.id">
<path
value="MedicinalProduct.Contraindication.OtherTherapySpecifics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.OtherTherapySpecifics.extension">
<path
value="MedicinalProduct.Contraindication.OtherTherapySpecifics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.OtherTherapySpecifics.modifierExtension">
<path
value="MedicinalProduct.Contraindication.OtherTherapySpecifics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType">
<path
value="MedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType"/>
<short
value="The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)"/>
<definition
value="The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.OtherTherapySpecifics.Medication">
<path
value="MedicinalProduct.Contraindication.OtherTherapySpecifics.Medication"/>
<short
value="Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)"/>
<definition
value="Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.OtherTherapySpecifics.Medication"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication.PopulationSpecifics">
<path value="MedicinalProduct.Contraindication.PopulationSpecifics"/>
<short value="9.9.2.5"/>
<definition value="9.9.2.5"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.Contraindication.PopulationSpecifics"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.Contraindication.PopulationSpecifics.id">
<path value="MedicinalProduct.Contraindication.PopulationSpecifics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.PopulationSpecifics.extension">
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.PopulationSpecifics.modifierExtension">
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.Contraindication.PopulationSpecifics.Age">
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.Age"/>
<short
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<definition
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.Age"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow">
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow"/>
<short
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<definition
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh">
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh"/>
<short
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<definition
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.PopulationSpecifics.Gender">
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.Gender"/>
<short
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<definition
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.Gender"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication.PopulationSpecifics.Race">
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.Race"/>
<short
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<definition
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.Race"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition">
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition"/>
<short
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<definition
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication.TherapeuticIndication">
<path value="MedicinalProduct.Contraindication.TherapeuticIndication"/>
<short value="9.9.2.2"/>
<definition value="9.9.2.2"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.Contraindication.TherapeuticIndication.id">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.extension">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.modifierExtension">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.IndicationText">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.IndicationText"/>
<short
value="The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)"/>
<definition
value="The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.IndicationText"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure"/>
<short
value="The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)"/>
<definition
value="The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus"/>
<short
value="The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)"/>
<definition
value="The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity"/>
<short
value="If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)"/>
<definition
value="If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect"/>
<short
value="The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)"/>
<definition
value="The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration"/>
<short
value="If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)"/>
<definition
value="If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics"/>
<short value="9.9.2.6"/>
<definition value="9.9.2.6"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.id">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.extension">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.modifierExtension">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType"/>
<short
value="The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)"/>
<definition
value="The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication"/>
<short
value="Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)"/>
<definition
value="Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics"/>
<short value="9.9.2.5"/>
<definition value="9.9.2.5"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.id">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.extension">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.modifierExtension">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age"/>
<short
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<definition
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeLow">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeLow"/>
<short
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<definition
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeLow"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh"/>
<short
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<definition
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender"/>
<short
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<definition
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race"/>
<short
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<definition
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition"/>
<short
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<definition
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects"/>
<short value="9.9.2.4"/>
<definition value="9.9.2.4"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.id">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.extension">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.modifierExtension">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText"/>
<short
value="The text of the undesirable effect shall be given. (9.9.2.4.2)"/>
<definition
value="The text of the undesirable effect shall be given. (9.9.2.4.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect"/>
<short
value="The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)"/>
<definition
value="The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification"/>
<short
value="The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)"/>
<definition
value="The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence"/>
<short
value="The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)"/>
<definition
value="The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics"/>
<short value="9.9.2.5"/>
<definition value="9.9.2.5"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.id">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age"/>
<short
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<definition
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow"/>
<short
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<definition
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh"/>
<short
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<definition
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender"/>
<short
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<definition
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race"/>
<short
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<definition
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition"/>
<short
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<definition
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Header">
<path value="MedicinalProduct.Header"/>
<short value="9.2.2.10"/>
<definition value="9.2.2.10"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.Header"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.Header.id">
<path value="MedicinalProduct.Header.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.Header.extension">
<path value="MedicinalProduct.Header.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.Header.modifierExtension">
<path value="MedicinalProduct.Header.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.Header.Identifier">
<path value="MedicinalProduct.Header.Identifier"/>
<short
value="This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)"/>
<definition
value="This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.Header.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.Header.EffectiveDate">
<path value="MedicinalProduct.Header.EffectiveDate"/>
<short
value="The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)"/>
<definition
value="The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.Header.EffectiveDate"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element id="MedicinalProduct.Header.Language">
<path value="MedicinalProduct.Header.Language"/>
<short
value="This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)"/>
<definition
value="This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.Header.Language"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Header.VersionNumber">
<path value="MedicinalProduct.Header.VersionNumber"/>
<short
value="This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)"/>
<definition
value="This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.Header.VersionNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.Header.VersionSetIdentifier">
<path value="MedicinalProduct.Header.VersionSetIdentifier"/>
<short
value="This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)"/>
<definition
value="This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.Header.VersionSetIdentifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.Interactions">
<path value="MedicinalProduct.Interactions"/>
<short value="9.9.2.7"/>
<definition value="9.9.2.7"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.Interactions"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.Interactions.id">
<path value="MedicinalProduct.Interactions.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.Interactions.extension">
<path value="MedicinalProduct.Interactions.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.Interactions.modifierExtension">
<path value="MedicinalProduct.Interactions.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.Interactions.InteractionsText">
<path value="MedicinalProduct.Interactions.InteractionsText"/>
<short
value="The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)"/>
<definition
value="The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.Interactions.InteractionsText"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.Interactions.Interactant">
<path value="MedicinalProduct.Interactions.Interactant"/>
<short
value="This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)"/>
<definition
value="This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.Interactions.Interactant"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Interactions.InteractionsType">
<path value="MedicinalProduct.Interactions.InteractionsType"/>
<short
value="The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)"/>
<definition
value="The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.Interactions.InteractionsType"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Interactions.InteractionsEffect">
<path value="MedicinalProduct.Interactions.InteractionsEffect"/>
<short
value="The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)"/>
<definition
value="The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.Interactions.InteractionsEffect"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Interactions.InteractionsIncidence">
<path value="MedicinalProduct.Interactions.InteractionsIncidence"/>
<short
value="The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)"/>
<definition
value="The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.Interactions.InteractionsIncidence"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Interactions.ManagementActions">
<path value="MedicinalProduct.Interactions.ManagementActions"/>
<short
value="The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)"/>
<definition
value="The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.Interactions.ManagementActions"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Manufacturer-Establishment-Organisation">
<path value="MedicinalProduct.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.id">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.extension">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.modifierExtension">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.id">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.extension">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MarketingAuthorisation">
<path value="MedicinalProduct.MarketingAuthorisation"/>
<short value="9.3.2.2"/>
<definition value="9.3.2.2"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.MarketingAuthorisation"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.MarketingAuthorisation.id">
<path value="MedicinalProduct.MarketingAuthorisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.MarketingAuthorisation.extension">
<path value="MedicinalProduct.MarketingAuthorisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.MarketingAuthorisation.modifierExtension">
<path
value="MedicinalProduct.MarketingAuthorisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber"/>
<short
value="The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)"/>
<definition
value="The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.MarketingAuthorisation.Country">
<path value="MedicinalProduct.MarketingAuthorisation.Country"/>
<short
value="The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)"/>
<definition
value="The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.MarketingAuthorisation.Country"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply">
<path
value="MedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply"/>
<short
value="The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)"/>
<definition
value="The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.AuthorisationStatus">
<path
value="MedicinalProduct.MarketingAuthorisation.AuthorisationStatus"/>
<short
value="The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)"/>
<definition
value="The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.AuthorisationStatus"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate">
<path
value="MedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate"/>
<short
value="The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)"/>
<definition
value="The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.ValidityPeriodStart">
<path
value="MedicinalProduct.MarketingAuthorisation.ValidityPeriodStart"/>
<short
value="The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)"/>
<definition
value="The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.ValidityPeriodStart"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element id="MedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd">
<path
value="MedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd"/>
<short
value="The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)"/>
<definition
value="The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate">
<path
value="MedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate"/>
<short
value="The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)"/>
<definition
value="The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate">
<path
value="MedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate"/>
<short
value="The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)"/>
<definition
value="The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation">
<path
value="MedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation"/>
<short
value="The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)"/>
<definition
value="The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.InternationalBirthDate">
<path
value="MedicinalProduct.MarketingAuthorisation.InternationalBirthDate"/>
<short
value="This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)"/>
<definition
value="This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.InternationalBirthDate"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation">
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation"/>
<short value="9.3.2.10"/>
<definition value="9.3.2.10"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.id">
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.extension">
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.modifierExtension">
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country">
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country"/>
<short
value="This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)"/>
<definition
value="This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction">
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction"/>
<short
value="This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)"/>
<definition
value="This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber">
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber"/>
<short
value="The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)"/>
<definition
value="The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply">
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply"/>
<short
value="The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)"/>
<definition
value="The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation"/>
<short value="9.3.2.3"/>
<definition value="9.3.2.3"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.id">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.extension">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.modifierExtension">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Identifier">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Name">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Address">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.id">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.extension">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Name">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Role">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME"/>
<short value="9.3.2.4"/>
<definition value="9.3.2.4"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.id">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.extension">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.modifierExtension">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMEFlag">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMEFlag"/>
<short
value="This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)"/>
<definition
value="This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMEFlag"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.Size">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.Size"/>
<short
value="The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)"/>
<definition
value="The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.Size"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMENumber">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMENumber"/>
<short
value="This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)"/>
<definition
value="This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMENumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.StatusDate">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.StatusDate"/>
<short
value="This is the date when the SME status was granted. (9.3.2.4.4)"/>
<definition
value="This is the date when the SME status was granted. (9.3.2.4.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.StatusDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure"/>
<short value="9.3.2.6"/>
<definition value="9.3.2.6"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.id">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.extension">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.modifierExtension">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number"/>
<short
value="The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)"/>
<definition
value="The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType"/>
<short
value="The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)"/>
<definition
value="The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart"/>
<short
value="The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)"/>
<definition
value="The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd"/>
<short
value="The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)"/>
<definition
value="The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication"/>
<short value="9.3.2.7"/>
<definition value="9.3.2.7"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.id">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.extension">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.modifierExtension">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number"/>
<short
value="A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)"/>
<definition
value="A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType"/>
<short
value="The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)"/>
<definition
value="The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate"/>
<short
value="The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)"/>
<definition
value="The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.id">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.extension">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.modifierExtension">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.id">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.extension">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MarketingAuthorisation.StatusReasons">
<path value="MedicinalProduct.MarketingAuthorisation.StatusReasons"/>
<short value="9.3.2.9"/>
<definition value="9.3.2.9"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.MarketingAuthorisation.StatusReasons"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.MarketingAuthorisation.StatusReasons.id">
<path value="MedicinalProduct.MarketingAuthorisation.StatusReasons.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.extension">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.modifierExtension">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.Reason">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.Reason"/>
<short
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<definition
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.Reason"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment"/>
<short
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<definition
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds"/>
<short
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<definition
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment"/>
<short
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<definition
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate"/>
<short
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<definition
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore"/>
<short
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<definition
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment"/>
<short
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<definition
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType"/>
<short
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<definition
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken"/>
<short
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<definition
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus">
<path value="MedicinalProduct.MarketingStatus"/>
<short value="9.3.2.8"/>
<definition value="9.3.2.8"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.MarketingStatus"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.MarketingStatus.id">
<path value="MedicinalProduct.MarketingStatus.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.MarketingStatus.extension">
<path value="MedicinalProduct.MarketingStatus.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.MarketingStatus.modifierExtension">
<path value="MedicinalProduct.MarketingStatus.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.MarketingStatus.Country">
<path value="MedicinalProduct.MarketingStatus.Country"/>
<short
value="The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)"/>
<definition
value="The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.MarketingStatus.Country"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.Jurisdiction">
<path value="MedicinalProduct.MarketingStatus.Jurisdiction"/>
<short
value="Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)"/>
<definition
value="Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.MarketingStatus.Jurisdiction"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.MarketingStatus">
<path value="MedicinalProduct.MarketingStatus.MarketingStatus"/>
<short
value="This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)"/>
<definition
value="This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.MarketingStatus.MarketingStatus"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.MarketingDateStart">
<path value="MedicinalProduct.MarketingStatus.MarketingDateStart"/>
<short
value="The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)"/>
<definition
value="The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.MarketingStatus.MarketingDateStart"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.MarketingDateStop">
<path value="MedicinalProduct.MarketingStatus.MarketingDateStop"/>
<short
value="The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)"/>
<definition
value="The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.MarketingStatus.MarketingDateStop"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.RiskOfSupplyShortage">
<path value="MedicinalProduct.MarketingStatus.RiskOfSupplyShortage"/>
<short
value="Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)"/>
<definition
value="Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.MarketingStatus.RiskOfSupplyShortage"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment">
<path
value="MedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment"/>
<short value="Any additional comment on supply shortage. (9.3.2.8.8)"/>
<definition
value="Any additional comment on supply shortage. (9.3.2.8.8)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.StatusReasons">
<path value="MedicinalProduct.MarketingStatus.StatusReasons"/>
<short value="9.3.2.9"/>
<definition value="9.3.2.9"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.MarketingStatus.StatusReasons"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.MarketingStatus.StatusReasons.id">
<path value="MedicinalProduct.MarketingStatus.StatusReasons.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.MarketingStatus.StatusReasons.extension">
<path value="MedicinalProduct.MarketingStatus.StatusReasons.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.modifierExtension">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.MarketingStatus.StatusReasons.Reason">
<path value="MedicinalProduct.MarketingStatus.StatusReasons.Reason"/>
<short
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<definition
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.MarketingStatus.StatusReasons.Reason"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.ReasonComment">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.ReasonComment"/>
<short
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<definition
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.ReasonComment"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds"/>
<short
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<definition
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment"/>
<short
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<definition
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.StatusReasons.RestoreDate">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.RestoreDate"/>
<short
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<definition
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.RestoreDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore"/>
<short
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<definition
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment"/>
<short
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<definition
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType"/>
<short
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<definition
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken"/>
<short
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<definition
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.MasterFile">
<path value="MedicinalProduct.MasterFile"/>
<short value="9.2.2.5"/>
<definition value="9.2.2.5"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.MasterFile"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.MasterFile.id">
<path value="MedicinalProduct.MasterFile.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.MasterFile.extension">
<path value="MedicinalProduct.MasterFile.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.MasterFile.modifierExtension">
<path value="MedicinalProduct.MasterFile.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.MasterFile.FileType">
<path value="MedicinalProduct.MasterFile.FileType"/>
<short
value="This attribute is to define which kind of master file is indicated (9.2.2.5.2)"/>
<definition
value="This attribute is to define which kind of master file is indicated (9.2.2.5.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.MasterFile.FileType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.MasterFile.FileCode">
<path value="MedicinalProduct.MasterFile.FileCode"/>
<short
value="This attribute is for a code to uniquely identify a master file. (9.2.2.5.3)"/>
<definition
value="This attribute is for a code to uniquely identify a master file. (9.2.2.5.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.MasterFile.FileCode"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation"/>
<short value="9.2.2.6"/>
<definition value="9.2.2.6"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.id">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.extension">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.modifierExtension">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Identifier">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Name">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Address">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.id">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.extension">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Name">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Role">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName">
<path value="MedicinalProduct.MedicinalProductName"/>
<short value="9.2.2.8"/>
<definition value="9.2.2.8"/>
<min value="1"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.MedicinalProductName"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.MedicinalProductName.id">
<path value="MedicinalProduct.MedicinalProductName.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.MedicinalProductName.extension">
<path value="MedicinalProduct.MedicinalProductName.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.MedicinalProductName.modifierExtension">
<path value="MedicinalProduct.MedicinalProductName.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.MedicinalProductName.FullName">
<path value="MedicinalProduct.MedicinalProductName.FullName"/>
<short
value="The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2)"/>
<definition
value="The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.MedicinalProductName.FullName"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.InventedNamePart">
<path value="MedicinalProduct.MedicinalProductName.InventedNamePart"/>
<short
value="The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)"/>
<definition
value="The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.MedicinalProductName.InventedNamePart"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.ScientificNamePart">
<path value="MedicinalProduct.MedicinalProductName.ScientificNamePart"/>
<short
value="The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)"/>
<definition
value="The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MedicinalProductName.ScientificNamePart"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.StrengthPart">
<path value="MedicinalProduct.MedicinalProductName.StrengthPart"/>
<short
value="The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)"/>
<definition
value="The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.MedicinalProductName.StrengthPart"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MedicinalProductName.PharmaceuticalDoseFormPart">
<path
value="MedicinalProduct.MedicinalProductName.PharmaceuticalDoseFormPart"/>
<short
value="The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)"/>
<definition
value="The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MedicinalProductName.PharmaceuticalDoseFormPart"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.FormulationPart">
<path value="MedicinalProduct.MedicinalProductName.FormulationPart"/>
<short
value="The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)"/>
<definition
value="The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.MedicinalProductName.FormulationPart"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.IntendedUsePart">
<path value="MedicinalProduct.MedicinalProductName.IntendedUsePart"/>
<short
value="The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)"/>
<definition
value="The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.MedicinalProductName.IntendedUsePart"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.TargetPopulationPart">
<path
value="MedicinalProduct.MedicinalProductName.TargetPopulationPart"/>
<short
value="The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)"/>
<definition
value="The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MedicinalProductName.TargetPopulationPart"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.ContainerOrPackPart">
<path
value="MedicinalProduct.MedicinalProductName.ContainerOrPackPart"/>
<short
value="The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)"/>
<definition
value="The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MedicinalProductName.ContainerOrPackPart"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.DevicePart">
<path value="MedicinalProduct.MedicinalProductName.DevicePart"/>
<short
value="The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)"/>
<definition
value="The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.MedicinalProductName.DevicePart"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MedicinalProductName.TrademarkOrCompanyNamePart">
<path
value="MedicinalProduct.MedicinalProductName.TrademarkOrCompanyNamePart"/>
<short
value="The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)"/>
<definition
value="The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.MedicinalProductName.TrademarkOrCompanyNamePart"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.Time-PeriodPart">
<path value="MedicinalProduct.MedicinalProductName.Time-PeriodPart"/>
<short
value="The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)"/>
<definition
value="The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.MedicinalProductName.Time-PeriodPart"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.FlavourPart">
<path value="MedicinalProduct.MedicinalProductName.FlavourPart"/>
<short
value="The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)"/>
<definition
value="The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.MedicinalProductName.FlavourPart"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.DelimiterPart">
<path value="MedicinalProduct.MedicinalProductName.DelimiterPart"/>
<short
value="A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)"/>
<definition
value="A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.MedicinalProductName.DelimiterPart"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.Country-Language">
<path value="MedicinalProduct.MedicinalProductName.Country-Language"/>
<short value="9.2.2.9"/>
<definition value="9.2.2.9"/>
<min value="1"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.MedicinalProductName.Country-Language"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.MedicinalProductName.Country-Language.id">
<path
value="MedicinalProduct.MedicinalProductName.Country-Language.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MedicinalProductName.Country-Language.extension">
<path
value="MedicinalProduct.MedicinalProductName.Country-Language.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.MedicinalProductName.Country-Language.modifierExtension">
<path
value="MedicinalProduct.MedicinalProductName.Country-Language.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.MedicinalProductName.Country-Language.Country">
<path
value="MedicinalProduct.MedicinalProductName.Country-Language.Country"/>
<short
value="The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)"/>
<definition
value="The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MedicinalProductName.Country-Language.Country"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MedicinalProductName.Country-Language.Jurisdiction">
<path
value="MedicinalProduct.MedicinalProductName.Country-Language.Jurisdiction"/>
<short
value="The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)"/>
<definition
value="The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MedicinalProductName.Country-Language.Jurisdiction"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MedicinalProductName.Country-Language.Language">
<path
value="MedicinalProduct.MedicinalProductName.Country-Language.Language"/>
<short
value="The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)"/>
<definition
value="The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.MedicinalProductName.Country-Language.Language"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.OrphanDesignation">
<path value="MedicinalProduct.OrphanDesignation"/>
<short value="9.2.2.3"/>
<definition value="9.2.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.OrphanDesignation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.OrphanDesignation.id">
<path value="MedicinalProduct.OrphanDesignation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.OrphanDesignation.extension">
<path value="MedicinalProduct.OrphanDesignation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.OrphanDesignation.modifierExtension">
<path value="MedicinalProduct.OrphanDesignation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.OrphanDesignation.OrphanIndicationType">
<path value="MedicinalProduct.OrphanDesignation.OrphanIndicationType"/>
<short
value="This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)"/>
<definition
value="This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.OrphanDesignation.OrphanIndicationType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.OrphanDesignation.OrphanProcedureNumber">
<path value="MedicinalProduct.OrphanDesignation.OrphanProcedureNumber"/>
<short
value="This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)"/>
<definition
value="This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.OrphanDesignation.OrphanProcedureNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus">
<path
value="MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus"/>
<short
value="This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)"/>
<definition
value="This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate">
<path
value="MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate"/>
<short
value="This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)"/>
<definition
value="This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element id="MedicinalProduct.OrphanDesignation.OrphanDesignationNumber">
<path
value="MedicinalProduct.OrphanDesignation.OrphanDesignationNumber"/>
<short
value="This field is to indicate the orphan designation decision number. (9.2.2.3.6)"/>
<definition
value="This field is to indicate the orphan designation decision number. (9.2.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.OrphanDesignation.OrphanDesignationNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.PackagedMedicinalProduct">
<path value="MedicinalProduct.PackagedMedicinalProduct"/>
<short value="9.6.2.2"/>
<definition value="9.6.2.2"/>
<min value="1"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.PackagedMedicinalProduct"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.PackagedMedicinalProduct.id">
<path value="MedicinalProduct.PackagedMedicinalProduct.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.PackagedMedicinalProduct.extension">
<path value="MedicinalProduct.PackagedMedicinalProduct.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.PackagedMedicinalProduct.PCID">
<path value="MedicinalProduct.PackagedMedicinalProduct.PCID"/>
<short
value="This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)"/>
<definition
value="This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.PackagedMedicinalProduct.PCID"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageDescription">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageDescription"/>
<short
value="A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)"/>
<definition
value="A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageDescription"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier"/>
<short value="9.6.2.8"/>
<definition value="9.6.2.8"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID1">
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID1"/>
<short
value="The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)"/>
<definition
value="The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID1"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID2">
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID2"/>
<short
value="The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)"/>
<definition
value="The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID2"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.ExpirationDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.ExpirationDate"/>
<short
value="This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)"/>
<definition
value="This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.ExpirationDate"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation"/>
<short value="9.3.2.2"/>
<definition value="9.3.2.2"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber"/>
<short
value="The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)"/>
<definition
value="The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.Country">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.Country"/>
<short
value="The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)"/>
<definition
value="The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.Country"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply"/>
<short
value="The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)"/>
<definition
value="The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatus">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatus"/>
<short
value="The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)"/>
<definition
value="The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatus"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate"/>
<short
value="The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)"/>
<definition
value="The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodStart">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodStart"/>
<short
value="The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)"/>
<definition
value="The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodStart"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd"/>
<short
value="The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)"/>
<definition
value="The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate"/>
<short
value="The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)"/>
<definition
value="The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate"/>
<short
value="The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)"/>
<definition
value="The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation"/>
<short
value="The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)"/>
<definition
value="The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.InternationalBirthDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.InternationalBirthDate"/>
<short
value="This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)"/>
<definition
value="This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.InternationalBirthDate"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation"/>
<short value="9.3.2.10"/>
<definition value="9.3.2.10"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country"/>
<short
value="This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)"/>
<definition
value="This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction"/>
<short
value="This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)"/>
<definition
value="This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber"/>
<short
value="The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)"/>
<definition
value="The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply"/>
<short
value="The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)"/>
<definition
value="The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation"/>
<short value="9.3.2.3"/>
<definition value="9.3.2.3"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME"/>
<short value="9.3.2.4"/>
<definition value="9.3.2.4"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMEFlag">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMEFlag"/>
<short
value="This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)"/>
<definition
value="This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMEFlag"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.Size">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.Size"/>
<short
value="The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)"/>
<definition
value="The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.Size"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMENumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMENumber"/>
<short
value="This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)"/>
<definition
value="This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMENumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.StatusDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.StatusDate"/>
<short
value="This is the date when the SME status was granted. (9.3.2.4.4)"/>
<definition
value="This is the date when the SME status was granted. (9.3.2.4.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.StatusDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure"/>
<short value="9.3.2.6"/>
<definition value="9.3.2.6"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number"/>
<short
value="The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)"/>
<definition
value="The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType"/>
<short
value="The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)"/>
<definition
value="The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart"/>
<short
value="The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)"/>
<definition
value="The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd"/>
<short
value="The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)"/>
<definition
value="The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication"/>
<short value="9.3.2.7"/>
<definition value="9.3.2.7"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number"/>
<short
value="A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)"/>
<definition
value="A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType"/>
<short
value="The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)"/>
<definition
value="The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate"/>
<short
value="The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)"/>
<definition
value="The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons"/>
<short value="9.3.2.9"/>
<definition value="9.3.2.9"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.Reason">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.Reason"/>
<short
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<definition
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.Reason"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment"/>
<short
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<definition
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds"/>
<short
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<definition
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment"/>
<short
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<definition
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate"/>
<short
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<definition
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore"/>
<short
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<definition
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment"/>
<short
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<definition
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType"/>
<short
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<definition
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken"/>
<short
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<definition
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus"/>
<short value="9.3.2.8"/>
<definition value="9.3.2.8"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Country">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Country"/>
<short
value="The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)"/>
<definition
value="The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Country"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Jurisdiction">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Jurisdiction"/>
<short
value="Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)"/>
<definition
value="Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Jurisdiction"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingStatus">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingStatus"/>
<short
value="This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)"/>
<definition
value="This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingStatus"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStart">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStart"/>
<short
value="The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)"/>
<definition
value="The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStart"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStop">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStop"/>
<short
value="The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)"/>
<definition
value="The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStop"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortage">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortage"/>
<short
value="Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)"/>
<definition
value="Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortage"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment"/>
<short value="Any additional comment on supply shortage. (9.3.2.8.8)"/>
<definition
value="Any additional comment on supply shortage. (9.3.2.8.8)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons"/>
<short value="9.3.2.9"/>
<definition value="9.3.2.9"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.Reason">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.Reason"/>
<short
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<definition
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.Reason"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ReasonComment">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ReasonComment"/>
<short
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<definition
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ReasonComment"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds"/>
<short
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<definition
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment"/>
<short
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<definition
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.RestoreDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.RestoreDate"/>
<short
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<definition
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.RestoreDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore"/>
<short
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<definition
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment"/>
<short
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<definition
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType"/>
<short
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<definition
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken"/>
<short
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<definition
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container"/>
<short value="9.6.2.3"/>
<definition value="9.6.2.3"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PackageItem_ContainerType"/>
<short
value="The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)"/>
<definition
value="The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PackageItem_ContainerType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerQuantity">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PackageItem_ContainerQuantity"/>
<short
value="The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)"/>
<definition
value="The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PackageItem_ContainerQuantity"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Material">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Material"/>
<short
value="The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)"/>
<definition
value="The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Material"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.AlternateMaterial">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.AlternateMaterial"/>
<short
value="The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)"/>
<definition
value="The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.AlternateMaterial"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier"/>
<short value="9.6.2.4"/>
<definition value="9.6.2.4"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.CodeSystem">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier.CodeSystem"/>
<short
value="The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)"/>
<definition
value="The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier.CodeSystem"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.Value">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier.Value"/>
<short
value="The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)"/>
<definition
value="The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier.Value"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device"/>
<short value="9.6.2.12"/>
<definition value="9.6.2.12"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceType"/>
<short
value="The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)"/>
<definition
value="The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceTradeName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceTradeName"/>
<short
value="This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)"/>
<definition
value="This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceTradeName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceQuantity">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceQuantity"/>
<short
value="The quantity of the device present in the pack shall be specified. (9.6.2.12.4)"/>
<definition
value="The quantity of the device present in the pack shall be specified. (9.6.2.12.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceQuantity"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceListingNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceListingNumber"/>
<short
value="This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)"/>
<definition
value="This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceListingNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceIdentifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceIdentifier"/>
<short
value="A unique device identifier needs to be specified. (9.6.2.12.6)"/>
<definition
value="A unique device identifier needs to be specified. (9.6.2.12.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceIdentifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ModelNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ModelNumber"/>
<short
value="This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)"/>
<definition
value="This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ModelNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.SterilityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.SterilityIndicator"/>
<short
value="Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)"/>
<definition
value="Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.SterilityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.SterilisationRequirementIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.SterilisationRequirementIndicator"/>
<short
value="Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)"/>
<definition
value="Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.SterilisationRequirementIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceUsage">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceUsage"/>
<short
value="The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)"/>
<definition
value="The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceUsage"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier"/>
<short value="9.6.2.15"/>
<definition value="9.6.2.15"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.BatchNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier.BatchNumber"/>
<short
value="Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)"/>
<definition
value="Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier.BatchNumber"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.ExpirationDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier.ExpirationDate"/>
<short
value="Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)"/>
<definition
value="Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier.ExpirationDate"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial"/>
<short value="9.6.2.13"/>
<definition value="9.6.2.13"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Substance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.Substance"/>
<short
value="The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)"/>
<definition
value="The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.Substance"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Alternate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.Alternate"/>
<short
value="This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)"/>
<definition
value="This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.Alternate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.AllergenicIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.AllergenicIndicator"/>
<short
value="This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)"/>
<definition
value="This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.AllergenicIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature"/>
<short value="9.6.2.14"/>
<definition value="9.6.2.14"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.CodeSystem">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature.CodeSystem"/>
<short
value="The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)"/>
<definition
value="The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature.CodeSystem"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.Value">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature.Value"/>
<short
value="The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)"/>
<definition
value="The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature.Value"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics"/>
<short value="9.6.2.22"/>
<definition value="9.6.2.22"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.CodeSystem">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics.CodeSystem"/>
<short
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<definition
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics.CodeSystem"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.Value">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics.Value"/>
<short
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<definition
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics.Value"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics"/>
<short value="9.6.2.21"/>
<definition value="9.6.2.21"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Height">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Height"/>
<short
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<definition
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Height"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Width">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Width"/>
<short
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<definition
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Width"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Depth">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Depth"/>
<short
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<definition
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Depth"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Weight">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Weight"/>
<short
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<definition
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Weight"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.NominalVolume">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.NominalVolume"/>
<short
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<definition
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.NominalVolume"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.ExternalDiameter">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.ExternalDiameter"/>
<short
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<definition
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.ExternalDiameter"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Shape">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Shape"/>
<short
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<definition
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Shape"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Colour">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Colour"/>
<short
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<definition
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Colour"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Imprint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Imprint"/>
<short
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<definition
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Imprint"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Image">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Image"/>
<short
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<definition
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Image"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ED"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Scoring">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Scoring"/>
<short
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<definition
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Scoring"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage"/>
<short value="9.6.2.11"/>
<definition value="9.6.2.11"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.ShelfLifeType"/>
<short
value="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)"/>
<definition
value="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.ShelfLifeType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod"/>
<short
value="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)"/>
<definition
value="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage"/>
<short
value="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)"/>
<definition
value="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem"/>
<short value="9.6.2.20"/>
<definition value="9.6.2.20"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedDoseForm">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.ManufacturedDoseForm"/>
<short
value="This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)"/>
<definition
value="This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.ManufacturedDoseForm"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.UnitOfPresentation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.UnitOfPresentation"/>
<short
value="This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)"/>
<definition
value="This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.UnitOfPresentation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedItemQuantity">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.ManufacturedItemQuantity"/>
<short
value="The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)"/>
<definition
value="The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.ManufacturedItemQuantity"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient"/>
<short value="9.7.2.2"/>
<definition value="9.7.2.2"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.IngredientRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.IngredientRole"/>
<short
value="The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)"/>
<definition
value="The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.IngredientRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.AllergenicIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.AllergenicIndicator"/>
<short
value="This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)"/>
<definition
value="This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.AllergenicIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance"/>
<short value="9.7.2.4"/>
<definition value="9.7.2.4"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance"/>
<short
value="When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)"/>
<definition
value="When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup"/>
<short
value="The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)"/>
<definition
value="The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)"/>
<definition
value="The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength"/>
<short value="9.7.2.5"/>
<definition value="9.7.2.5"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength_Presentation"/>
<short
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<definition
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength_Presentation"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength_Concentration"/>
<short
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<definition
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength_Concentration"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint"/>
<short
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<definition
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country"/>
<short
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<definition
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength"/>
<short value="9.7.2.6"/>
<definition value="9.7.2.6"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance"/>
<short
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<definition
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"/>
<short
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<definition
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength"/>
<short
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<definition
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"/>
<short
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<definition
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry"/>
<short
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<definition
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance"/>
<short value="9.7.2.3"/>
<definition value="9.7.2.3"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Substance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Substance"/>
<short
value="A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)"/>
<definition
value="A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Substance"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength"/>
<short value="9.7.2.5"/>
<definition value="9.7.2.5"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Presentation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.Strength_Presentation"/>
<short
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<definition
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.Strength_Presentation"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Concentration">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.Strength_Concentration"/>
<short
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<definition
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.Strength_Concentration"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint"/>
<short
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<definition
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Country">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.Country"/>
<short
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<definition
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.Country"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength"/>
<short value="9.7.2.6"/>
<definition value="9.7.2.6"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance"/>
<short
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<definition
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"/>
<short
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<definition
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength"/>
<short
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<definition
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"/>
<short
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<definition
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry"/>
<short
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<definition
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics"/>
<short value="9.6.2.22"/>
<definition value="9.6.2.22"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.CodeSystem">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics.CodeSystem"/>
<short
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<definition
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics.CodeSystem"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.Value">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics.Value"/>
<short
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<definition
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics.Value"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics"/>
<short value="9.6.2.21"/>
<definition value="9.6.2.21"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Height">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Height"/>
<short
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<definition
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Height"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Width">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Width"/>
<short
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<definition
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Width"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Depth">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Depth"/>
<short
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<definition
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Depth"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Weight">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Weight"/>
<short
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<definition
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Weight"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume"/>
<short
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<definition
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter"/>
<short
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<definition
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Shape">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Shape"/>
<short
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<definition
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Shape"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Colour">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Colour"/>
<short
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<definition
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Colour"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Imprint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Imprint"/>
<short
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<definition
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Imprint"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Image">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Image"/>
<short
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<definition
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Image"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ED"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Scoring">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Scoring"/>
<short
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<definition
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Scoring"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics"/>
<short value="9.6.2.22"/>
<definition value="9.6.2.22"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.CodeSystem">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics.CodeSystem"/>
<short
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<definition
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics.CodeSystem"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.Value">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics.Value"/>
<short
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<definition
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics.Value"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component"/>
<short value="9.6.2.9"/>
<definition value="9.6.2.9"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.ComponentType"/>
<short
value="The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)"/>
<definition
value="The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.ComponentType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentMaterial">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.ComponentMaterial"/>
<short
value="The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)"/>
<definition
value="The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.ComponentMaterial"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentAlternateMaterial">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.ComponentAlternateMaterial"/>
<short
value="Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)"/>
<definition
value="Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.ComponentAlternateMaterial"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics"/>
<short value="9.6.2.21"/>
<definition value="9.6.2.21"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Height">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Height"/>
<short
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<definition
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Height"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Width">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Width"/>
<short
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<definition
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Width"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Depth">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Depth"/>
<short
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<definition
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Depth"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Weight">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Weight"/>
<short
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<definition
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Weight"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.NominalVolume">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.NominalVolume"/>
<short
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<definition
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.NominalVolume"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.ExternalDiameter">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.ExternalDiameter"/>
<short
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<definition
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.ExternalDiameter"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Shape">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Shape"/>
<short
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<definition
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Shape"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Colour">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Colour"/>
<short
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<definition
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Colour"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Imprint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Imprint"/>
<short
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<definition
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Imprint"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Image">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Image"/>
<short
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<definition
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Image"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ED"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Scoring">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Scoring"/>
<short
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<definition
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Scoring"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics"/>
<short value="9.6.2.21"/>
<definition value="9.6.2.21"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Height">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Height"/>
<short
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<definition
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Height"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Width">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Width"/>
<short
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<definition
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Width"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Depth">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Depth"/>
<short
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<definition
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Depth"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Weight">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Weight"/>
<short
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<definition
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Weight"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.NominalVolume">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.NominalVolume"/>
<short
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<definition
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.NominalVolume"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.ExternalDiameter">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.ExternalDiameter"/>
<short
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<definition
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.ExternalDiameter"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Shape">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Shape"/>
<short
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<definition
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Shape"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Colour">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Colour"/>
<short
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<definition
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Colour"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Imprint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Imprint"/>
<short
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<definition
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Imprint"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Image">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Image"/>
<short
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<definition
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Image"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ED"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Scoring">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Scoring"/>
<short
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<definition
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Scoring"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage"/>
<short value="9.6.2.11"/>
<definition value="9.6.2.11"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.id">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.extension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.modifierExtension">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.ShelfLifeType"/>
<short
value="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)"/>
<definition
value="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.ShelfLifeType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeTimePeriod">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.ShelfLifeTimePeriod"/>
<short
value="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)"/>
<definition
value="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.ShelfLifeTimePeriod"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.SpecialPrecautionsForStorage">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.SpecialPrecautionsForStorage"/>
<short
value="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)"/>
<definition
value="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.SpecialPrecautionsForStorage"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct">
<path value="MedicinalProduct.PharmaceuticalProduct"/>
<short value="9.8.2.2"/>
<definition value="9.8.2.2"/>
<min value="1"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.PharmaceuticalProduct"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.id">
<path value="MedicinalProduct.PharmaceuticalProduct.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.extension">
<path value="MedicinalProduct.PharmaceuticalProduct.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.modifierExtension">
<path value="MedicinalProduct.PharmaceuticalProduct.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm">
<path
value="MedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm"/>
<short
value="This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)"/>
<definition
value="This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.UnitOfPresentation">
<path
value="MedicinalProduct.PharmaceuticalProduct.UnitOfPresentation"/>
<short
value="The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)"/>
<definition
value="The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.UnitOfPresentation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.Device">
<path value="MedicinalProduct.PharmaceuticalProduct.Device"/>
<short value="9.6.2.12"/>
<definition value="9.6.2.12"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.PharmaceuticalProduct.Device"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.Device.id">
<path value="MedicinalProduct.PharmaceuticalProduct.Device.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.Device.extension">
<path value="MedicinalProduct.PharmaceuticalProduct.Device.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceType">
<path value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceType"/>
<short
value="The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)"/>
<definition
value="The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName"/>
<short
value="This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)"/>
<definition
value="This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity"/>
<short
value="The quantity of the device present in the pack shall be specified. (9.6.2.12.4)"/>
<definition
value="The quantity of the device present in the pack shall be specified. (9.6.2.12.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber"/>
<short
value="This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)"/>
<definition
value="This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier"/>
<short
value="A unique device identifier needs to be specified. (9.6.2.12.6)"/>
<definition
value="A unique device identifier needs to be specified. (9.6.2.12.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.Device.ModelNumber">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ModelNumber"/>
<short
value="This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)"/>
<definition
value="This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ModelNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator"/>
<short
value="Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)"/>
<definition
value="Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator"/>
<short
value="Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)"/>
<definition
value="Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage"/>
<short
value="The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)"/>
<definition
value="The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier"/>
<short value="9.6.2.15"/>
<definition value="9.6.2.15"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber"/>
<short
value="Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)"/>
<definition
value="Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate"/>
<short
value="Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)"/>
<definition
value="Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial"/>
<short value="9.6.2.13"/>
<definition value="9.6.2.13"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance"/>
<short
value="The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)"/>
<definition
value="The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate"/>
<short
value="This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)"/>
<definition
value="This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator"/>
<short
value="This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)"/>
<definition
value="This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature"/>
<short value="9.6.2.14"/>
<definition value="9.6.2.14"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem"/>
<short
value="The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)"/>
<definition
value="The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value"/>
<short
value="The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)"/>
<definition
value="The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics"/>
<short value="9.6.2.22"/>
<definition value="9.6.2.22"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem"/>
<short
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<definition
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value"/>
<short
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<definition
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics"/>
<short value="9.6.2.21"/>
<definition value="9.6.2.21"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height"/>
<short
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<definition
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width"/>
<short
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<definition
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth"/>
<short
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<definition
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight"/>
<short
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<definition
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume"/>
<short
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<definition
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter"/>
<short
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<definition
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape"/>
<short
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<definition
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour"/>
<short
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<definition
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint"/>
<short
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<definition
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image"/>
<short
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<definition
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ED"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring"/>
<short
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<definition
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage"/>
<short value="9.6.2.11"/>
<definition value="9.6.2.11"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType"/>
<short
value="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)"/>
<definition
value="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod"/>
<short
value="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)"/>
<definition
value="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage"/>
<short
value="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)"/>
<definition
value="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.Ingredient">
<path value="MedicinalProduct.PharmaceuticalProduct.Ingredient"/>
<short value="9.7.2.2"/>
<definition value="9.7.2.2"/>
<min value="1"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.PharmaceuticalProduct.Ingredient"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.Ingredient.id">
<path value="MedicinalProduct.PharmaceuticalProduct.Ingredient.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole"/>
<short
value="The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)"/>
<definition
value="The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator"/>
<short
value="This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)"/>
<definition
value="This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance"/>
<short value="9.7.2.4"/>
<definition value="9.7.2.4"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance"/>
<short
value="When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)"/>
<definition
value="When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup"/>
<short
value="The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)"/>
<definition
value="The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)"/>
<definition
value="The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength"/>
<short value="9.7.2.5"/>
<definition value="9.7.2.5"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength_Presentation"/>
<short
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<definition
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength_Presentation"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength_Concentration"/>
<short
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<definition
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength_Concentration"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint"/>
<short
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<definition
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country"/>
<short
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<definition
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength"/>
<short value="9.7.2.6"/>
<definition value="9.7.2.6"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance"/>
<short
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<definition
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"/>
<short
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<definition
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength"/>
<short
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<definition
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"/>
<short
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<definition
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry"/>
<short
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<definition
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance"/>
<short value="9.7.2.3"/>
<definition value="9.7.2.3"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance"/>
<short
value="A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)"/>
<definition
value="A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength"/>
<short value="9.7.2.5"/>
<definition value="9.7.2.5"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Presentation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength_Presentation"/>
<short
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<definition
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength_Presentation"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Concentration">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength_Concentration"/>
<short
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<definition
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength_Concentration"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint"/>
<short
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<definition
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country"/>
<short
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<definition
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength"/>
<short value="9.7.2.6"/>
<definition value="9.7.2.6"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance"/>
<short
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<definition
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"/>
<short
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<definition
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength"/>
<short
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<definition
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"/>
<short
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<definition
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry"/>
<short
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<definition
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics">
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics"/>
<short value="9.8.2.4"/>
<definition value="9.8.2.4"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem">
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem"/>
<short
value="The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)"/>
<definition
value="The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value">
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value"/>
<short
value="The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)"/>
<definition
value="The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status">
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status"/>
<short
value="The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)"/>
<definition
value="The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.PhPIDSet">
<path value="MedicinalProduct.PharmaceuticalProduct.PhPIDSet"/>
<short value="9.8.2.6"/>
<definition value="9.8.2.6"/>
<min value="1"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.PharmaceuticalProduct.PhPIDSet"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.PhPIDSet.id">
<path value="MedicinalProduct.PharmaceuticalProduct.PhPIDSet.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.PhPIDSet.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.PhPIDSet.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.PhPIDSet.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.PhPIDSet.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets">
<path
value="MedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets"/>
<short
value="This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)"/>
<definition
value="This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration">
<path
value="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration"/>
<short value="9.8.2.3"/>
<definition value="9.8.2.3"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.id">
<path
value="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.extension">
<path
value="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.modifierExtension">
<path
value="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.RouteOfAdministration">
<path
value="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.RouteOfAdministration"/>
<short
value="The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0)"/>
<definition
value="The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.RouteOfAdministration"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.ProductClassification">
<path value="MedicinalProduct.ProductClassification"/>
<short value="9.2.2.4"/>
<definition value="9.2.2.4"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.ProductClassification"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.ProductClassification.id">
<path value="MedicinalProduct.ProductClassification.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.ProductClassification.extension">
<path value="MedicinalProduct.ProductClassification.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.ProductClassification.modifierExtension">
<path value="MedicinalProduct.ProductClassification.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.ProductClassification.CodeSystem">
<path value="MedicinalProduct.ProductClassification.CodeSystem"/>
<short
value="The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)"/>
<definition
value="The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.ProductClassification.CodeSystem"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.ProductClassification.Value">
<path value="MedicinalProduct.ProductClassification.Value"/>
<short
value="The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)"/>
<definition
value="The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.ProductClassification.Value"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.ProductCross-Reference">
<path value="MedicinalProduct.ProductCross-Reference"/>
<short value="9.2.2.7"/>
<definition value="9.2.2.7"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.ProductCross-Reference"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.ProductCross-Reference.id">
<path value="MedicinalProduct.ProductCross-Reference.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.ProductCross-Reference.extension">
<path value="MedicinalProduct.ProductCross-Reference.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.ProductCross-Reference.modifierExtension">
<path
value="MedicinalProduct.ProductCross-Reference.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.ProductCross-Reference.I-MPIDCross-Reference">
<path
value="MedicinalProduct.ProductCross-Reference.I_MPIDCross-Reference"/>
<short
value="This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)"/>
<definition
value="This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.ProductCross-Reference.I_MPIDCross-Reference"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.ProductCross-Reference.ReferencedProductType">
<path
value="MedicinalProduct.ProductCross-Reference.ReferencedProductType"/>
<short
value="This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)"/>
<definition
value="This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.ProductCross-Reference.ReferencedProductType"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.TherapeuticIndication">
<path value="MedicinalProduct.TherapeuticIndication"/>
<short value="9.9.2.2"/>
<definition value="9.9.2.2"/>
<min value="1"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.TherapeuticIndication"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.TherapeuticIndication.id">
<path value="MedicinalProduct.TherapeuticIndication.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.TherapeuticIndication.extension">
<path value="MedicinalProduct.TherapeuticIndication.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.TherapeuticIndication.modifierExtension">
<path value="MedicinalProduct.TherapeuticIndication.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.TherapeuticIndication.IndicationText">
<path value="MedicinalProduct.TherapeuticIndication.IndicationText"/>
<short
value="The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)"/>
<definition
value="The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.TherapeuticIndication.IndicationText"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure">
<path
value="MedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure"/>
<short
value="The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)"/>
<definition
value="The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.TherapeuticIndication.DiseaseStatus">
<path value="MedicinalProduct.TherapeuticIndication.DiseaseStatus"/>
<short
value="The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)"/>
<definition
value="The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.TherapeuticIndication.DiseaseStatus"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.TherapeuticIndication.Comorbidity">
<path value="MedicinalProduct.TherapeuticIndication.Comorbidity"/>
<short
value="If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)"/>
<definition
value="If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.TherapeuticIndication.Comorbidity"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.TherapeuticIndication.IntendedEffect">
<path value="MedicinalProduct.TherapeuticIndication.IntendedEffect"/>
<short
value="The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)"/>
<definition
value="The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.TherapeuticIndication.IntendedEffect"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.TherapeuticIndication.Timing-Duration">
<path value="MedicinalProduct.TherapeuticIndication.Timing-Duration"/>
<short
value="If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)"/>
<definition
value="If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProduct.TherapeuticIndication.Timing-Duration"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics">
<path
value="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics"/>
<short value="9.9.2.6"/>
<definition value="9.9.2.6"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.id">
<path
value="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.extension">
<path
value="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.modifierExtension">
<path
value="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType">
<path
value="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType"/>
<short
value="The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)"/>
<definition
value="The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.Medication">
<path
value="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.Medication"/>
<short
value="Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)"/>
<definition
value="Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.OtherTherapySpecifics.Medication"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.TherapeuticIndication.PopulationSpecifics">
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics"/>
<short value="9.9.2.5"/>
<definition value="9.9.2.5"/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics"/>
<min value="1"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.id">
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.extension">
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.modifierExtension">
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Age">
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Age"/>
<short
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<definition
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Age"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeLow">
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeLow"/>
<short
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<definition
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeLow"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh">
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh"/>
<short
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<definition
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.AgeRangeHigh"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Gender">
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Gender"/>
<short
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<definition
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Gender"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Race">
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Race"/>
<short
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<definition
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.Race"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition">
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition"/>
<short
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<definition
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.TherapeuticIndication.UndesirableEffects">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects"/>
<short value="9.9.2.4"/>
<definition value="9.9.2.4"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.id">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.extension">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.modifierExtension">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectText">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectText"/>
<short
value="The text of the undesirable effect shall be given. (9.9.2.4.2)"/>
<definition
value="The text of the undesirable effect shall be given. (9.9.2.4.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectText"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect"/>
<short
value="The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)"/>
<definition
value="The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification"/>
<short
value="The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)"/>
<definition
value="The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence"/>
<short
value="The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)"/>
<definition
value="The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics"/>
<short value="9.9.2.5"/>
<definition value="9.9.2.5"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.id">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age"/>
<short
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<definition
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age"/>
<min value="0"/>
<max value="1"/>
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<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow"/>
<short
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<definition
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
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<max value="1"/>
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<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh"/>
<short
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<definition
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh"/>
<min value="0"/>
<max value="1"/>
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<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender"/>
<short
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<definition
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
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<min value="0"/>
<max value="1"/>
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<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race"/>
<short
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<definition
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition">
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition"/>
<short
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<definition
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.UndesirableEffects">
<path value="MedicinalProduct.UndesirableEffects"/>
<short value="9.9.2.4"/>
<definition value="9.9.2.4"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProduct.UndesirableEffects"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.UndesirableEffects.id">
<path value="MedicinalProduct.UndesirableEffects.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.UndesirableEffects.extension">
<path value="MedicinalProduct.UndesirableEffects.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProduct.UndesirableEffects.modifierExtension">
<path value="MedicinalProduct.UndesirableEffects.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="MedicinalProduct.UndesirableEffects.UndesirableEffectText">
<path
value="MedicinalProduct.UndesirableEffects.UndesirableEffectText"/>
<short
value="The text of the undesirable effect shall be given. (9.9.2.4.2)"/>
<definition
value="The text of the undesirable effect shall be given. (9.9.2.4.2)"/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.UndesirableEffects.UndesirableEffectText"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect">
<path
value="MedicinalProduct.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect"/>
<short
value="The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)"/>
<definition
value="The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.UndesirableEffects.Symptom-Condition-EffectClassification">
<path
value="MedicinalProduct.UndesirableEffects.Symptom-Condition-EffectClassification"/>
<short
value="The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)"/>
<definition
value="The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.UndesirableEffects.Symptom-Condition-EffectClassification"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.UndesirableEffects.FrequencyOfOccurrence">
<path
value="MedicinalProduct.UndesirableEffects.FrequencyOfOccurrence"/>
<short
value="The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)"/>
<definition
value="The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.UndesirableEffects.FrequencyOfOccurrence"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.UndesirableEffects.PopulationSpecifics">
<path value="MedicinalProduct.UndesirableEffects.PopulationSpecifics"/>
<short value="9.9.2.5"/>
<definition value="9.9.2.5"/>
<min value="0"/>
<max value="*"/>
<base>
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="MedicinalProduct.UndesirableEffects.PopulationSpecifics.id">
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.UndesirableEffects.PopulationSpecifics.extension">
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="MedicinalProduct.UndesirableEffects.PopulationSpecifics.modifierExtension">
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element
id="MedicinalProduct.UndesirableEffects.PopulationSpecifics.Age">
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.Age"/>
<short
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<definition
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.Age"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeLow">
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeLow"/>
<short
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<definition
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeLow"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeHigh">
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeHigh"/>
<short
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<definition
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.AgeRangeHigh"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.UndesirableEffects.PopulationSpecifics.Gender">
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.Gender"/>
<short
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<definition
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.Gender"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.UndesirableEffects.PopulationSpecifics.Race">
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.Race"/>
<short
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<definition
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.Race"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition">
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition"/>
<short
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<definition
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
</snapshot>
<differential>
<element id="MedicinalProduct">
<path value="MedicinalProduct"/>
<definition value="ISO 11615 Authorised Medicinal Product"/>
</element>
<element id="MedicinalProduct.MPID">
<path value="MedicinalProduct.MPID"/>
<short
value="This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2)"/>
<definition
value="This is the MPID for the Medicinal Product, which shall be always specified. It is specified as text. (9.2.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.CombinedPharmaceuticalDoseForm">
<path value="MedicinalProduct.CombinedPharmaceuticalDoseForm"/>
<short
value="The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3)"/>
<definition
value="The combined pharmaceutical dose form is a single term to describe two or more manufactured items that are intended to be combined in a specific way to produce a single pharmaceutical product. It includes information on the manufactured dose form of each manufactured item and the administrable dose form of the pharmaceutical product. If the Medicinal Product requires description of a combined pharmaceutical dose form, it can be specified here using a term and a term identifier as defined in ISO 11239 and the resulting terminology. (9.2.2.2.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.AdditionalMonitoringIndicator">
<path value="MedicinalProduct.AdditionalMonitoringIndicator"/>
<short
value="If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4)"/>
<definition
value="If the Medicinal Product is subject to additional monitoring, this can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.SpecialMeasures">
<path value="MedicinalProduct.SpecialMeasures"/>
<short
value="If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5)"/>
<definition
value="If the Medicinal Product is subject to specific special measures, these can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.2.5)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.PaediatricUseIndicator">
<path value="MedicinalProduct.PaediatricUseIndicator"/>
<short
value="This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6)"/>
<definition
value="This is a flag that indicates if the Medicinal Product is also authorised for use in children. (9.2.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.OrphanDesignationStatus">
<path value="MedicinalProduct.OrphanDesignationStatus"/>
<short
value="The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7)"/>
<definition
value="The description if the Medicinal Product is subject to orphan designation and intended for the treatment of a rare disease. (9.2.2.2.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument">
<path value="MedicinalProduct.AttachedDocument"/>
<short value="9.2.2.11"/>
<definition value="9.2.2.11"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.Identifier">
<path value="MedicinalProduct.AttachedDocument.Identifier"/>
<short
value="The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)"/>
<definition
value="The reference to the regulatory decision document related to the granting of the authorisation or the latest update of the regulated product information shall be specified in text. (9.2.2.11.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.EffectiveDate">
<path value="MedicinalProduct.AttachedDocument.EffectiveDate"/>
<short
value="The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)"/>
<definition
value="The date corresponding to a version of a regulated document containing regulated Medicinal Product information (e.g. elements related to the summary of product characteristics, product labelling). A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE Document version date corresponds to the tracking versions of a regulated document. It does not correspond to the actual revisions or regulatory timelines that may be captured within a regulated document. (9.2.2.11.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.Type">
<path value="MedicinalProduct.AttachedDocument.Type"/>
<short
value="The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)"/>
<definition
value="The type of document that is supporting a version increment shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.2.2.11.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.Content">
<path value="MedicinalProduct.AttachedDocument.Content"/>
<short
value="The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)"/>
<definition
value="The actual document that is supporting a version increment shall be attached. The format of the document attachment shall be specified by regional implementations. (9.2.2.11.5)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ED"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.Language">
<path value="MedicinalProduct.AttachedDocument.Language"/>
<short
value="This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)"/>
<definition
value="This attribute defines the language used for the information related to the regulatory submission. (9.2.2.11.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.MediaType">
<path value="MedicinalProduct.AttachedDocument.MediaType"/>
<short
value="This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)"/>
<definition
value="This attributes is used to define the graphic media type of the attached document. (9.2.2.11.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.VersionNumber">
<path value="MedicinalProduct.AttachedDocument.VersionNumber"/>
<short
value="This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)"/>
<definition
value="This is a number identifying a specific version of the attached regulatory document. (9.2.2.11.8)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.AttachedDocument.VersionSetIdentifier">
<path value="MedicinalProduct.AttachedDocument.VersionSetIdentifier"/>
<short
value="This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)"/>
<definition
value="This is a number used to group together a set of specific versions of the same regulatory document. (9.2.2.11.9)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication">
<path value="MedicinalProduct.Contraindication"/>
<short value="9.9.2.3"/>
<definition value="9.9.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication.ContraindicationsText">
<path value="MedicinalProduct.Contraindication.ContraindicationsText"/>
<short
value="The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)"/>
<definition
value="The text of the contraindication(s) in line with the regulated product information shall be described. (9.9.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure">
<path
value="MedicinalProduct.Contraindication.ContraindicationsAsDisease-Symptom-Procedure"/>
<short
value="The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)"/>
<definition
value="The underlying disease, symptom or procedure of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication.DiseaseStatus">
<path value="MedicinalProduct.Contraindication.DiseaseStatus"/>
<short
value="The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)"/>
<definition
value="The status of the disease or symptom of the contraindication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication.Comorbidity">
<path value="MedicinalProduct.Contraindication.Comorbidity"/>
<short
value="The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)"/>
<definition
value="The comorbidity (concurrent condition) or coinfection shall be specified. (9.9.2.3.5)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication.OtherTherapySpecifics">
<path value="MedicinalProduct.Contraindication.OtherTherapySpecifics"/>
<short value="9.9.2.6"/>
<definition value="9.9.2.6"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType">
<path
value="MedicinalProduct.Contraindication.OtherTherapySpecifics.TherapyRelationshipType"/>
<short
value="The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)"/>
<definition
value="The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.OtherTherapySpecifics.Medication">
<path
value="MedicinalProduct.Contraindication.OtherTherapySpecifics.Medication"/>
<short
value="Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)"/>
<definition
value="Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication.PopulationSpecifics">
<path value="MedicinalProduct.Contraindication.PopulationSpecifics"/>
<short value="9.9.2.5"/>
<definition value="9.9.2.5"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication.PopulationSpecifics.Age">
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.Age"/>
<short
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<definition
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow">
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeLow"/>
<short
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<definition
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh">
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.AgeRangeHigh"/>
<short
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<definition
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.PopulationSpecifics.Gender">
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.Gender"/>
<short
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<definition
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication.PopulationSpecifics.Race">
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.Race"/>
<short
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<definition
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition">
<path
value="MedicinalProduct.Contraindication.PopulationSpecifics.PhysiologicalCondition"/>
<short
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<definition
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Contraindication.TherapeuticIndication">
<path value="MedicinalProduct.Contraindication.TherapeuticIndication"/>
<short value="9.9.2.2"/>
<definition value="9.9.2.2"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.IndicationText">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.IndicationText"/>
<short
value="The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)"/>
<definition
value="The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure"/>
<short
value="The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)"/>
<definition
value="The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.DiseaseStatus"/>
<short
value="The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)"/>
<definition
value="The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.Comorbidity"/>
<short
value="If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)"/>
<definition
value="If there is any comorbidity (concurrent condition) or co-infection described as part of the indication as it is referenced in the regulated product information, it can be specified here using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.5)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
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</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.IntendedEffect"/>
<short
value="The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)"/>
<definition
value="The intended effect, aim or strategy to be achieved by the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. NOTE The intended effect is specifically the part of the indication that describes the type of outcome or result intended for the target condition, whereas the indication is the full text description of the benefits from the medicine for the target condition in the target population. (9.9.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
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</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.Timing-Duration"/>
<short
value="If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)"/>
<definition
value="If there is timing or duration information described as part of the indication as it is referenced in the regulated product information, it can be specified here. (9.9.2.2.7)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
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<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics"/>
<short value="9.9.2.6"/>
<definition value="9.9.2.6"/>
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<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
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</element>
<element
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<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.TherapyRelationshipType"/>
<short
value="The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)"/>
<definition
value="The type of relationship between the Medicinal Product indication or contraindication and a specific other therapy shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.2)"/>
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<code value="Element"/>
<profile
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<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.OtherTherapySpecifics.Medication"/>
<short
value="Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)"/>
<definition
value="Reference to a specific medication, which can be expressed as an active substance, Medicinal Product or class of Medicinal Products, as part of a specific indication or contraindication in accordance with the regulated product information shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.6.3)"/>
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<code value="Element"/>
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<element
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<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics"/>
<short value="9.9.2.5"/>
<definition value="9.9.2.5"/>
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<type>
<code value="BackboneElement"/>
<profile
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<element
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<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Age"/>
<short
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<definition
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
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<element
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<path
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<short
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<definition
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
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<element
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<path
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<short
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<definition
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
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<element
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<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Gender"/>
<short
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<definition
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
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<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.Race"/>
<short
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<definition
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.PopulationSpecifics.PhysiologicalCondition"/>
<short
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<definition
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects"/>
<short value="9.9.2.4"/>
<definition value="9.9.2.4"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectText"/>
<short
value="The text of the undesirable effect shall be given. (9.9.2.4.2)"/>
<definition
value="The text of the undesirable effect shall be given. (9.9.2.4.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.UndesirableEffectAsSymptom-Condition-Effect"/>
<short
value="The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)"/>
<definition
value="The symptom, condition or effect in relation to the undesirable effect as described in the regulated product information can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.Symptom-Condition-EffectClassification"/>
<short
value="The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)"/>
<definition
value="The classification of the “symptom/condition/effect” can be specified. The controlled term and the controlled term identifier shall be specified using an appropriate controlled vocabulary. (9.9.2.4.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.FrequencyOfOccurrence"/>
<short
value="The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)"/>
<definition
value="The frequency of occurrence of the “symptom/condition/effect” can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics"/>
<short value="9.9.2.5"/>
<definition value="9.9.2.5"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Age"/>
<short
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<definition
value="The age of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeLow"/>
<short
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<definition
value="The lower limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.AgeRangeHigh"/>
<short
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<definition
value="The upper limit of the age range of the specific population for an indication or a contraindication as authorised for the Medicinal Product in accordance with the regulated product information can be specified. Either age or age range should be specified for a single indication/contraindication; both should not be specified. (9.9.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Gender"/>
<short
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<definition
value="The gender of the specific population for an indication or a contraindication in accordance with the regulated product information shall be specified using ISO/IEC 5218 . (9.9.2.5.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.Race"/>
<short
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<definition
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition">
<path
value="MedicinalProduct.Contraindication.TherapeuticIndication.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition"/>
<short
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<definition
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Header">
<path value="MedicinalProduct.Header"/>
<short value="9.2.2.10"/>
<definition value="9.2.2.10"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element id="MedicinalProduct.Header.Identifier">
<path value="MedicinalProduct.Header.Identifier"/>
<short
value="This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)"/>
<definition
value="This attribute is for the unique code identifying the regulatory information submission. (9.2.2.10.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.Header.EffectiveDate">
<path value="MedicinalProduct.Header.EffectiveDate"/>
<short
value="The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)"/>
<definition
value="The date specified in the regulatory decision document by which the authorisation or the updates to the regulated product information become effective shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.2.2.10.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element id="MedicinalProduct.Header.Language">
<path value="MedicinalProduct.Header.Language"/>
<short
value="This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)"/>
<definition
value="This attribute defines the language used for the information related to the regulatory submission. (9.2.2.10.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Header.VersionNumber">
<path value="MedicinalProduct.Header.VersionNumber"/>
<short
value="This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)"/>
<definition
value="This is a number identifying a specific version of the regulatory information submission. (9.2.2.10.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.Header.VersionSetIdentifier">
<path value="MedicinalProduct.Header.VersionSetIdentifier"/>
<short
value="This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)"/>
<definition
value="This is a number used to group together a set of specific versions of the regulatory information submission. (9.2.2.10.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.Interactions">
<path value="MedicinalProduct.Interactions"/>
<short value="9.9.2.7"/>
<definition value="9.9.2.7"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element id="MedicinalProduct.Interactions.InteractionsText">
<path value="MedicinalProduct.Interactions.InteractionsText"/>
<short
value="The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)"/>
<definition
value="The text of the interaction in accordance with the regulated product information shall be provided. (9.9.2.7.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.Interactions.Interactant">
<path value="MedicinalProduct.Interactions.Interactant"/>
<short
value="This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)"/>
<definition
value="This element can be used to describe the specific medication, food or laboratory test that is the secondary interactant of the interaction as described in the regulated product information. For more information, refer to regional implementation guides. (9.9.2.7.3)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Interactions.InteractionsType">
<path value="MedicinalProduct.Interactions.InteractionsType"/>
<short
value="The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)"/>
<definition
value="The type of interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Interactions.InteractionsEffect">
<path value="MedicinalProduct.Interactions.InteractionsEffect"/>
<short
value="The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)"/>
<definition
value="The effect of the interaction in line with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Interactions.InteractionsIncidence">
<path value="MedicinalProduct.Interactions.InteractionsIncidence"/>
<short
value="The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)"/>
<definition
value="The incidence of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Interactions.ManagementActions">
<path value="MedicinalProduct.Interactions.ManagementActions"/>
<short
value="The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)"/>
<definition
value="The actions to provide management of the interaction in accordance with the regulated product information can be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.7.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.Manufacturer-Establishment-Organisation">
<path value="MedicinalProduct.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MarketingAuthorisation">
<path value="MedicinalProduct.MarketingAuthorisation"/>
<short value="9.3.2.2"/>
<definition value="9.3.2.2"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber"/>
<short
value="The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)"/>
<definition
value="The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.MarketingAuthorisation.Country">
<path value="MedicinalProduct.MarketingAuthorisation.Country"/>
<short
value="The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)"/>
<definition
value="The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply">
<path
value="MedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply"/>
<short
value="The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)"/>
<definition
value="The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.AuthorisationStatus">
<path
value="MedicinalProduct.MarketingAuthorisation.AuthorisationStatus"/>
<short
value="The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)"/>
<definition
value="The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate">
<path
value="MedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate"/>
<short
value="The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)"/>
<definition
value="The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.ValidityPeriodStart">
<path
value="MedicinalProduct.MarketingAuthorisation.ValidityPeriodStart"/>
<short
value="The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)"/>
<definition
value="The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element id="MedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd">
<path
value="MedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd"/>
<short
value="The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)"/>
<definition
value="The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate">
<path
value="MedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate"/>
<short
value="The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)"/>
<definition
value="The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate">
<path
value="MedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate"/>
<short
value="The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)"/>
<definition
value="The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation">
<path
value="MedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation"/>
<short
value="The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)"/>
<definition
value="The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.InternationalBirthDate">
<path
value="MedicinalProduct.MarketingAuthorisation.InternationalBirthDate"/>
<short
value="This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)"/>
<definition
value="This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation">
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation"/>
<short value="9.3.2.10"/>
<definition value="9.3.2.10"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country">
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country"/>
<short
value="This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)"/>
<definition
value="This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction">
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction"/>
<short
value="This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)"/>
<definition
value="This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber">
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber"/>
<short
value="The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)"/>
<definition
value="The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply">
<path
value="MedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply"/>
<short
value="The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)"/>
<definition
value="The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation"/>
<short value="9.3.2.3"/>
<definition value="9.3.2.3"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Identifier">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Name">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Address">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Name">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Role">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME"/>
<short value="9.3.2.4"/>
<definition value="9.3.2.4"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMEFlag">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMEFlag"/>
<short
value="This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)"/>
<definition
value="This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.Size">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.Size"/>
<short
value="The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)"/>
<definition
value="The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMENumber">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMENumber"/>
<short
value="This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)"/>
<definition
value="This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.StatusDate">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.StatusDate"/>
<short
value="This is the date when the SME status was granted. (9.3.2.4.4)"/>
<definition
value="This is the date when the SME status was granted. (9.3.2.4.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure"/>
<short value="9.3.2.6"/>
<definition value="9.3.2.6"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number"/>
<short
value="The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)"/>
<definition
value="The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType"/>
<short
value="The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)"/>
<definition
value="The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart"/>
<short
value="The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)"/>
<definition
value="The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd"/>
<short
value="The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)"/>
<definition
value="The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication"/>
<short value="9.3.2.7"/>
<definition value="9.3.2.7"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number"/>
<short
value="A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)"/>
<definition
value="A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType"/>
<short
value="The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)"/>
<definition
value="The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate">
<path
value="MedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate"/>
<short
value="The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)"/>
<definition
value="The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MarketingAuthorisation.StatusReasons">
<path value="MedicinalProduct.MarketingAuthorisation.StatusReasons"/>
<short value="9.3.2.9"/>
<definition value="9.3.2.9"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.Reason">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.Reason"/>
<short
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<definition
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment"/>
<short
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<definition
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds"/>
<short
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<definition
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment"/>
<short
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<definition
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate"/>
<short
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<definition
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore"/>
<short
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<definition
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment"/>
<short
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<definition
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType"/>
<short
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<definition
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken">
<path
value="MedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken"/>
<short
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<definition
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus">
<path value="MedicinalProduct.MarketingStatus"/>
<short value="9.3.2.8"/>
<definition value="9.3.2.8"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.Country">
<path value="MedicinalProduct.MarketingStatus.Country"/>
<short
value="The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)"/>
<definition
value="The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.Jurisdiction">
<path value="MedicinalProduct.MarketingStatus.Jurisdiction"/>
<short
value="Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)"/>
<definition
value="Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.MarketingStatus">
<path value="MedicinalProduct.MarketingStatus.MarketingStatus"/>
<short
value="This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)"/>
<definition
value="This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.MarketingDateStart">
<path value="MedicinalProduct.MarketingStatus.MarketingDateStart"/>
<short
value="The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)"/>
<definition
value="The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.MarketingDateStop">
<path value="MedicinalProduct.MarketingStatus.MarketingDateStop"/>
<short
value="The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)"/>
<definition
value="The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.RiskOfSupplyShortage">
<path value="MedicinalProduct.MarketingStatus.RiskOfSupplyShortage"/>
<short
value="Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)"/>
<definition
value="Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment">
<path
value="MedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment"/>
<short value="Any additional comment on supply shortage. (9.3.2.8.8)"/>
<definition
value="Any additional comment on supply shortage. (9.3.2.8.8)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.StatusReasons">
<path value="MedicinalProduct.MarketingStatus.StatusReasons"/>
<short value="9.3.2.9"/>
<definition value="9.3.2.9"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.StatusReasons.Reason">
<path value="MedicinalProduct.MarketingStatus.StatusReasons.Reason"/>
<short
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<definition
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.ReasonComment">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.ReasonComment"/>
<short
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<definition
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds"/>
<short
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<definition
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment"/>
<short
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<definition
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MarketingStatus.StatusReasons.RestoreDate">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.RestoreDate"/>
<short
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<definition
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore"/>
<short
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<definition
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment"/>
<short
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<definition
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType"/>
<short
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<definition
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken">
<path
value="MedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken"/>
<short
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<definition
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.MasterFile">
<path value="MedicinalProduct.MasterFile"/>
<short value="9.2.2.5"/>
<definition value="9.2.2.5"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element id="MedicinalProduct.MasterFile.FileType">
<path value="MedicinalProduct.MasterFile.FileType"/>
<short
value="This attribute is to define which kind of master file is indicated (9.2.2.5.2)"/>
<definition
value="This attribute is to define which kind of master file is indicated (9.2.2.5.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.MasterFile.FileCode">
<path value="MedicinalProduct.MasterFile.FileCode"/>
<short
value="This attribute is for a code to uniquely identify a master file. (9.2.2.5.3)"/>
<definition
value="This attribute is for a code to uniquely identify a master file. (9.2.2.5.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation"/>
<short value="9.2.2.6"/>
<definition value="9.2.2.6"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Identifier">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Name">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Address">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Name">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.Role">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.MasterFile.MasterFileHolder-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.MasterFile.MasterFileHolder_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName">
<path value="MedicinalProduct.MedicinalProductName"/>
<short value="9.2.2.8"/>
<definition value="9.2.2.8"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.FullName">
<path value="MedicinalProduct.MedicinalProductName.FullName"/>
<short
value="The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2)"/>
<definition
value="The full and complete Medicinal Product name as approved by the Medicines Regulatory Agency in a regions shall be specified, as text. (9.2.2.8.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.InventedNamePart">
<path value="MedicinalProduct.MedicinalProductName.InventedNamePart"/>
<short
value="The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)"/>
<definition
value="The invented name (i.e. trade name) of the Medicinal Product without the trademark or any other similar designations reflected in the Medicinal Product name can be specified as text, where applicable. (9.2.2.8.3)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.ScientificNamePart">
<path value="MedicinalProduct.MedicinalProductName.ScientificNamePart"/>
<short
value="The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)"/>
<definition
value="The scientific or common (i.e. generic) name of the Medicinal Product without any other descriptors can be specified as text, where applicable. (9.2.2.8.4)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.StrengthPart">
<path value="MedicinalProduct.MedicinalProductName.StrengthPart"/>
<short
value="The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)"/>
<definition
value="The strength, if reflected in the Medicinal Product name, can be specified as text, where applicable. This strength name part can differ from the concept of “Strength” as described in 9.7 . (9.2.2.8.5)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MedicinalProductName.PharmaceuticalDoseFormPart">
<path
value="MedicinalProduct.MedicinalProductName.PharmaceuticalDoseFormPart"/>
<short
value="The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)"/>
<definition
value="The pharmaceutical dose form, if reflected in the Medicinal Product name, can be specified as text, where applicable. This pharmaceutical dose form name part can differ from the concept of administrable dose form and manufactured dose form as described in ISO / TS 20443 . (9.2.2.8.6)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.FormulationPart">
<path value="MedicinalProduct.MedicinalProductName.FormulationPart"/>
<short
value="The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)"/>
<definition
value="The formulation, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.7)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.IntendedUsePart">
<path value="MedicinalProduct.MedicinalProductName.IntendedUsePart"/>
<short
value="The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)"/>
<definition
value="The intended use, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.8)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.TargetPopulationPart">
<path
value="MedicinalProduct.MedicinalProductName.TargetPopulationPart"/>
<short
value="The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)"/>
<definition
value="The target population, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.9)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.ContainerOrPackPart">
<path
value="MedicinalProduct.MedicinalProductName.ContainerOrPackPart"/>
<short
value="The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)"/>
<definition
value="The container or pack, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.10)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.DevicePart">
<path value="MedicinalProduct.MedicinalProductName.DevicePart"/>
<short
value="The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)"/>
<definition
value="The device, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.11)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.MedicinalProductName.TrademarkOrCompanyNamePart">
<path
value="MedicinalProduct.MedicinalProductName.TrademarkOrCompanyNamePart"/>
<short
value="The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)"/>
<definition
value="The trademark, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.12)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.Time-PeriodPart">
<path value="MedicinalProduct.MedicinalProductName.Time-PeriodPart"/>
<short
value="The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)"/>
<definition
value="The time/period, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.13)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.FlavourPart">
<path value="MedicinalProduct.MedicinalProductName.FlavourPart"/>
<short
value="The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)"/>
<definition
value="The flavour, if reflected in the Medicinal Product name, can be specified as text, where applicable. (9.2.2.8.14)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.DelimiterPart">
<path value="MedicinalProduct.MedicinalProductName.DelimiterPart"/>
<short
value="A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)"/>
<definition
value="A delimiter separates one composite in a segment from another or separates one subcomposite from another. (9.2.2.8.15)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.MedicinalProductName.Country-Language">
<path value="MedicinalProduct.MedicinalProductName.Country-Language"/>
<short value="9.2.2.9"/>
<definition value="9.2.2.9"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.MedicinalProductName.Country-Language.Country">
<path
value="MedicinalProduct.MedicinalProductName.Country-Language.Country"/>
<short
value="The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)"/>
<definition
value="The country where the Medicinal Product name is applicable shall be described using ISO 3166 - 1 alpha-2 code elements. (9.2.2.9.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MedicinalProductName.Country-Language.Jurisdiction">
<path
value="MedicinalProduct.MedicinalProductName.Country-Language.Jurisdiction"/>
<short
value="The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)"/>
<definition
value="The jurisdiction within the country where the Medicinal Product name is applicable can be described using an appropriate controlled vocabulary, if appropriate. The controlled term and the controlled term identifier shall be specified. (9.2.2.9.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.MedicinalProductName.Country-Language.Language">
<path
value="MedicinalProduct.MedicinalProductName.Country-Language.Language"/>
<short
value="The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)"/>
<definition
value="The language of the Medicinal Product name as applicable in the specified country and jurisdiction if appropriate shall be specified using ISO 639 - 1 . (9.2.2.9.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.OrphanDesignation">
<path value="MedicinalProduct.OrphanDesignation"/>
<short value="9.2.2.3"/>
<definition value="9.2.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element id="MedicinalProduct.OrphanDesignation.OrphanIndicationType">
<path value="MedicinalProduct.OrphanDesignation.OrphanIndicationType"/>
<short
value="This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)"/>
<definition
value="This attribute is for the type of intended use of the Medicinal Product, for instance disease prevention, treatment or diagnostic. (9.2.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.OrphanDesignation.OrphanProcedureNumber">
<path value="MedicinalProduct.OrphanDesignation.OrphanProcedureNumber"/>
<short
value="This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)"/>
<definition
value="This attribute is the procedure number for the orphan designation authorisation application. (9.2.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus">
<path
value="MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationStatus"/>
<short
value="This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)"/>
<definition
value="This attribute is for describing the status of the orphan designation authorisation, for instance granted, pending, expired or withdrawn. (9.2.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate">
<path
value="MedicinalProduct.OrphanDesignation.OrphanDesignationAuthorisationDate"/>
<short
value="This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)"/>
<definition
value="This attribute is for the date in which the orphan designation status was granted. (9.2.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element id="MedicinalProduct.OrphanDesignation.OrphanDesignationNumber">
<path
value="MedicinalProduct.OrphanDesignation.OrphanDesignationNumber"/>
<short
value="This field is to indicate the orphan designation decision number. (9.2.2.3.6)"/>
<definition
value="This field is to indicate the orphan designation decision number. (9.2.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.PackagedMedicinalProduct">
<path value="MedicinalProduct.PackagedMedicinalProduct"/>
<short value="9.6.2.2"/>
<definition value="9.6.2.2"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element id="MedicinalProduct.PackagedMedicinalProduct.PCID">
<path value="MedicinalProduct.PackagedMedicinalProduct.PCID"/>
<short
value="This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)"/>
<definition
value="This is the unique identifier for the Packaged Medicinal Product, constructed as described in 8.3 . (9.6.2.2.1)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageDescription">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageDescription"/>
<short
value="A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)"/>
<definition
value="A textual description of the Packaged Medicinal Product shall be provided. (9.6.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element id="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier"/>
<short value="9.6.2.8"/>
<definition value="9.6.2.8"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID1">
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID1"/>
<short
value="The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)"/>
<definition
value="The BAID1, which appears on the outer packaging of a specific batch of the Medicinal Product, shall be specified. Since there will be many different batches of any one Packaged Medicinal Product, and since the specification of batch identification might not always be required for each type of Packaged Medicinal Product, the cardinality of the relationship between the Packaged Medicinal Product and the batch identifier is given as 0...*. In situations where a Packaged Medicinal Product contains more than one manufactured item and/or includes a device, this batch number refers to the one given on the outermost packaging. (9.6.2.8.1)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID2">
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.BAID2"/>
<short
value="The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)"/>
<definition
value="The BAID2, which appears on the immediate packaging and is not the outer packaging, shall be specified. (9.6.2.8.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.ExpirationDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.BatchIdentifier.ExpirationDate"/>
<short
value="This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)"/>
<definition
value="This is the date the manufacturer guarantees the full potency and safety of a particular batch/lot of Medicinal Product. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.6.2.8.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation"/>
<short value="9.3.2.2"/>
<definition value="9.3.2.2"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationNumber"/>
<short
value="The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)"/>
<definition
value="The number as assigned to a Medicinal Product by the Regulatory Medicines Agency of a country or jurisdiction shall be specified in text. For Medicinal Products which allow distribution without a marketing authorisation by legislation, the licensing number as it appears on the package, the container or the package insert shall be specified in the absence of a formal marketing authorisation number (e.g. for “grandfather” drugs in the US). (9.3.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.Country">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.Country"/>
<short
value="The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)"/>
<definition
value="The country in which the marketing authorisation has been granted shall be provided in accordance with the ISO 3166 - 1 alpha-2 code elements. (9.3.2.2.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.LegalStatusOfSupply"/>
<short
value="The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)"/>
<definition
value="The legal status of supply of the Medicinal Product as classified by the Medicines Regulatory Agency shall be specified (e.g. subject to medical prescription or not). The legal status of supply shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. Legal status of supply may be a defining element for the Medicinal Product within a region to support regulatory, compliance and pharmacovigilance activities. (9.3.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatus">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatus"/>
<short
value="The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)"/>
<definition
value="The status of the marketing authorisation changes throughout the lifecycle of a Medicinal Product depending on the regulatory process applicable in a region. This shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.2.5)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.AuthorisationStatusDate"/>
<short
value="The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)"/>
<definition
value="The date at which the given status has become applicable shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.6)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodStart">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodStart"/>
<short
value="The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)"/>
<definition
value="The beginning of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.7)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.ValidityPeriodEnd"/>
<short
value="The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)"/>
<definition
value="The end of the time period in which the marketing authorisation is in the specific status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.8)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityStartDate"/>
<short
value="The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)"/>
<definition
value="The “data exclusivity period” is a period of time from initial authorisation of the reference product after which valid applications for generic product can be submitted and lead to the granting of a marketing authorisation. The beginning of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.9)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DataExclusivityEndDate"/>
<short
value="The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)"/>
<definition
value="The end of the data exclusivity period for the relevant status shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.2.10)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.DateOfFirstAuthorisation"/>
<short
value="The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)"/>
<definition
value="The date when the first authorisation was granted by a Medicines Regulatory Agency. (9.3.2.2.11)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.InternationalBirthDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.InternationalBirthDate"/>
<short
value="This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)"/>
<definition
value="This is the date of first marketing authorisation for a company’s new Medicinal Product in any country in the world. (9.3.2.2.12)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation"/>
<short value="9.3.2.10"/>
<definition value="9.3.2.10"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Country"/>
<short
value="This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)"/>
<definition
value="This attribute defines the country to which the jurisdictional marketing authorisation refers to. (9.3.2.10.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.Jurisdiction"/>
<short
value="This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)"/>
<definition
value="This attribute indicates which jurisdiction the jurisdictional marketing authorisation is related to. (9.3.2.10.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.MarketingAuthorisationNumber"/>
<short
value="The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)"/>
<definition
value="The number for the marketing authorisation assigned by a Medicines Regulatory Authority in the jurisdiction can be specified in text. (9.3.2.10.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.JurisdictionalMarketingAuthorisation.LegalStatusOfSupply"/>
<short
value="The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)"/>
<definition
value="The legal status of supply for the Medicinal Product as applicable in a region/jurisdiction can be described using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.10.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation"/>
<short value="9.3.2.3"/>
<definition value="9.3.2.3"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME"/>
<short value="9.3.2.4"/>
<definition value="9.3.2.4"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMEFlag">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMEFlag"/>
<short
value="This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)"/>
<definition
value="This is a flag to indicate if the organisation is an SME. (9.3.2.4.1)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.Size">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.Size"/>
<short
value="The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)"/>
<definition
value="The size of the SME needs to be specified, i.e. micro, small or medium. For the definition of the values, refer to ISO / TS 20443 . (9.3.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.SMENumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.SMENumber"/>
<short
value="This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)"/>
<definition
value="This is a unique number that it is uniquely identifying an SME. (9.3.2.4.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder-Organisation.SME.StatusDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationHolder_Organisation.SME.StatusDate"/>
<short
value="This is the date when the SME status was granted. (9.3.2.4.4)"/>
<definition
value="This is the date when the SME status was granted. (9.3.2.4.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure"/>
<short value="9.3.2.6"/>
<definition value="9.3.2.6"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureIdentifier-Number"/>
<short
value="The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)"/>
<definition
value="The unique identifier for the specific instance of a procedure undertaken shall be provided in text. (9.3.2.6.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureType"/>
<short
value="The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)"/>
<definition
value="The type of procedure that is followed to grant or update a marketing authorisation shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.6.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateStart"/>
<short
value="The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)"/>
<definition
value="The initial date when the procedure commenced shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.ProcedureDateEnd"/>
<short
value="The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)"/>
<definition
value="The end date when the procedure completed shall be described. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.6.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication"/>
<short value="9.3.2.7"/>
<definition value="9.3.2.7"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationIdentifier-Number"/>
<short
value="A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)"/>
<definition
value="A unique identifier for the specific instance of an application shall be provided in text. The application identifier/number is usually assigned by a Medicines Regulatory Agency. (9.3.2.7.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationType"/>
<short
value="The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)"/>
<definition
value="The type of the application shall be described using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.7.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MarketingAuthorisationProcedure.MarketingAuthorisationApplication.ApplicationDate"/>
<short
value="The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)"/>
<definition
value="The date on which the marketing authorisation application was made shall be specified. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.7.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
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<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons"/>
<short value="9.3.2.9"/>
<definition value="9.3.2.9"/>
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<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
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<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.Reason">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.Reason"/>
<short
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<definition
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ReasonComment"/>
<short
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<definition
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGrounds"/>
<short
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<definition
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.LegalGroundsComment"/>
<short
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<definition
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.RestoreDate"/>
<short
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<definition
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestore"/>
<short
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<definition
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ConditionToRestoreComment"/>
<short
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<definition
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.ChangeRequestOrganisationType"/>
<short
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<definition
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingAuthorisation.StatusReasons.GeographicAreaForActionTaken"/>
<short
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<definition
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus"/>
<short value="9.3.2.8"/>
<definition value="9.3.2.8"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Country">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Country"/>
<short
value="The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)"/>
<definition
value="The country in which the marketing authorisation has been granted shall be specified. It should be specified using the ISO 3166 - 1 alpha-2 code elements. (9.3.2.8.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Jurisdiction">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.Jurisdiction"/>
<short
value="Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)"/>
<definition
value="Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.3.2.8.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingStatus">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingStatus"/>
<short
value="This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)"/>
<definition
value="This attribute provides information on the status of the marketing of the Medicinal Product. See ISO / T S 20443 for more information and examples. (9.3.2.8.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStart">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStart"/>
<short
value="The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)"/>
<definition
value="The date when the Medicinal Product is placed on the market by the marketing authorisation holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain. (9.3.2.8.5)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStop">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.MarketingDateStop"/>
<short
value="The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)"/>
<definition
value="The date when the Medicinal Product is no longer available on the market in a country and/or jurisdiction shall be provided. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. NOTE “No longer available on the market” can refer to the fact that the marketing authorisation holder has taken a decision to no longer market the Medicinal Product or that the marketing authorisation is no longer valid. (9.3.2.8.6)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortage">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortage"/>
<short
value="Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)"/>
<definition
value="Indication on whether there is a risk of a product shortage in a region. (9.3.2.8.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.RiskOfSupplyShortageComment"/>
<short value="Any additional comment on supply shortage. (9.3.2.8.8)"/>
<definition
value="Any additional comment on supply shortage. (9.3.2.8.8)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons"/>
<short value="9.3.2.9"/>
<definition value="9.3.2.9"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.Reason">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.Reason"/>
<short
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<definition
value="The reason for a legal action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ReasonComment">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ReasonComment"/>
<short
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<definition
value="Additional comment(s) on the reason for a legal action taken on the marketing or on the marketing authorisation. (9.3.2.9.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
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</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGrounds"/>
<short
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<definition
value="The legal grounds of the action taken on the marketing or on the marketing authorisation can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.LegalGroundsComment"/>
<short
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<definition
value="Any additional description of the action taken on the marketing or on the marketing authorisation. (9.3.2.9.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.RestoreDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.RestoreDate"/>
<short
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<definition
value="The date when the marketing or the marketing authorisation of the product is anticipated to be restored. A complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.3.2.9.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestore"/>
<short
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<definition
value="The condition under which the marketing authorisation or the marketing is restored can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ConditionToRestoreComment"/>
<short
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<definition
value="Additional comments on the condition to restore the marketing or the marketing authorisation of the product. (9.3.2.9.8)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.ChangeRequestOrganisationType"/>
<short
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<definition
value="The organisation that triggered the legal action taken on the marketing or on the marketing authorisation (e.g. marketing authorisation revoked by the competent authority, marketing authorisation not renewed by the MAH) can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.9)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken">
<path
value="MedicinalProduct.PackagedMedicinalProduct.MarketingStatus.StatusReasons.GeographicAreaForActionTaken"/>
<short
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<definition
value="The geographic area where the legal action taken on the marketing or the on marketing authorisation is having effect can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.3.2.9.10)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container"/>
<short value="9.6.2.3"/>
<definition value="9.6.2.3"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PackageItem_ContainerType"/>
<short
value="The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)"/>
<definition
value="The package item (container) type shall be specified to describe the physical type of the container of the medicine in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. A term and a term identifier shall be specified. (9.6.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PackageItem-ContainerQuantity">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PackageItem_ContainerQuantity"/>
<short
value="The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)"/>
<definition
value="The quantity (or count number) of the package item shall be specified. Because the package item class recurses to describe containers within containers, the first (outermost) container shall always have a quantity of “1”. (9.6.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Material">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Material"/>
<short
value="The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)"/>
<definition
value="The material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology as applicable. A term and a term identifier shall be specified. (9.6.2.3.4)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.AlternateMaterial">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.AlternateMaterial"/>
<short
value="The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)"/>
<definition
value="The alternate material(s) of the package item shall be described in accordance with ISO 11238 and ISO / TS 1 9844 and its resulting terminology as applicable. A term and a term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a blister sleeve). (9.6.2.3.5)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier"/>
<short value="9.6.2.4"/>
<definition value="9.6.2.4"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.CodeSystem">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier.CodeSystem"/>
<short
value="The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)"/>
<definition
value="The data carrier identification system itself shall be specified using an appropriate identification system. (9.6.2.4.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.DataCarrierIdentifier.Value">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.DataCarrierIdentifier.Value"/>
<short
value="The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)"/>
<definition
value="The individual value from the identification system that applies to the Packaged Medicinal Product shall be specified. (9.6.2.4.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device"/>
<short value="9.6.2.12"/>
<definition value="9.6.2.12"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceType"/>
<short
value="The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)"/>
<definition
value="The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceTradeName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceTradeName"/>
<short
value="This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)"/>
<definition
value="This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceQuantity">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceQuantity"/>
<short
value="The quantity of the device present in the pack shall be specified. (9.6.2.12.4)"/>
<definition
value="The quantity of the device present in the pack shall be specified. (9.6.2.12.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceListingNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceListingNumber"/>
<short
value="This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)"/>
<definition
value="This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceIdentifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceIdentifier"/>
<short
value="A unique device identifier needs to be specified. (9.6.2.12.6)"/>
<definition
value="A unique device identifier needs to be specified. (9.6.2.12.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ModelNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ModelNumber"/>
<short
value="This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)"/>
<definition
value="This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.SterilityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.SterilityIndicator"/>
<short
value="Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)"/>
<definition
value="Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.SterilisationRequirementIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.SterilisationRequirementIndicator"/>
<short
value="Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)"/>
<definition
value="Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceUsage">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceUsage"/>
<short
value="The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)"/>
<definition
value="The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier"/>
<short value="9.6.2.15"/>
<definition value="9.6.2.15"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.BatchNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier.BatchNumber"/>
<short
value="Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)"/>
<definition
value="Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceBatchIdentifier.ExpirationDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceBatchIdentifier.ExpirationDate"/>
<short
value="Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)"/>
<definition
value="Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial"/>
<short value="9.6.2.13"/>
<definition value="9.6.2.13"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Substance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.Substance"/>
<short
value="The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)"/>
<definition
value="The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.Alternate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.Alternate"/>
<short
value="This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)"/>
<definition
value="This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceMaterial.AllergenicIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceMaterial.AllergenicIndicator"/>
<short
value="This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)"/>
<definition
value="This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature"/>
<short value="9.6.2.14"/>
<definition value="9.6.2.14"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.CodeSystem">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature.CodeSystem"/>
<short
value="The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)"/>
<definition
value="The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.DeviceNomenclature.Value">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.DeviceNomenclature.Value"/>
<short
value="The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)"/>
<definition
value="The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
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<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
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<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
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value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
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value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
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<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
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<element
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<path
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<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
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<element
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<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
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<type>
<code value="BackboneElement"/>
<profile
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<element
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<path
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<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
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<element
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<path
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<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
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<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics"/>
<short value="9.6.2.22"/>
<definition value="9.6.2.22"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.CodeSystem">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics.CodeSystem"/>
<short
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<definition
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.OtherCharacteristics.Value">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.OtherCharacteristics.Value"/>
<short
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<definition
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics"/>
<short value="9.6.2.21"/>
<definition value="9.6.2.21"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Height">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Height"/>
<short
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<definition
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Width">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Width"/>
<short
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<definition
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Depth">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Depth"/>
<short
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<definition
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Weight">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Weight"/>
<short
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<definition
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.NominalVolume">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.NominalVolume"/>
<short
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<definition
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.ExternalDiameter">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.ExternalDiameter"/>
<short
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<definition
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Shape">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Shape"/>
<short
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<definition
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Colour">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Colour"/>
<short
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<definition
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Imprint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Imprint"/>
<short
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<definition
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Image">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Image"/>
<short
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<definition
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ED"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.PhysicalCharacteristics.Scoring">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.PhysicalCharacteristics.Scoring"/>
<short
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<definition
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage"/>
<short value="9.6.2.11"/>
<definition value="9.6.2.11"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.ShelfLifeType"/>
<short
value="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)"/>
<definition
value="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.ShelfLifeTimePeriod"/>
<short
value="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)"/>
<definition
value="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Device.ShelfLife-Storage.SpecialPrecautionsForStorage"/>
<short
value="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)"/>
<definition
value="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem"/>
<short value="9.6.2.20"/>
<definition value="9.6.2.20"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedDoseForm">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.ManufacturedDoseForm"/>
<short
value="This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)"/>
<definition
value="This describes the pharmaceutical dose form of the manufactured item, where applicable, before transformation into the pharmaceutical product. The manufactured dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. A Medicinal Product may have two package items, e.g. one with a manufactured dose form of powder for solution for injection and the other with a manufactured dose form of solvent for solution for injection. These are then to be transformed to a solution for injection before the medicine can be administered to a patient. Powder and solvent for solution for injection is the “combined pharmaceutical dose form”, which is an attribute of “Medicinal Product” and solution for injection is the “administrable dose form”, which is an attribute of “pharmaceutical product”. (9.6.2.20.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.UnitOfPresentation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.UnitOfPresentation"/>
<short
value="This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)"/>
<definition
value="This specifies the “real world” units in which the quantity of the manufactured item is described. The unit of presentation can be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and the controlled term identifier shall be specified. For items where their quantity is a measured quantity of weight or volume, the “unit of presentation” shall not be given since it is the same as the units of that quantity (that is ml, mg or %). For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.ManufacturedItemQuantity">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.ManufacturedItemQuantity"/>
<short
value="The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)"/>
<definition
value="The quantity (or count number) of the manufactured item shall be described. It shall be specified as a value and units, and the units shall be specified as a symbol and a symbol identifier as defined in ISO 11240 and the resulting terminology. For solid dose forms and other items that are measured by counting integer quantities, the unit for quantity shall be “unit” and the “unit of presentation” shall be the item that is counted. (9.6.2.20.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient"/>
<short value="9.7.2.2"/>
<definition value="9.7.2.2"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.IngredientRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.IngredientRole"/>
<short
value="The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)"/>
<definition
value="The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.AllergenicIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.AllergenicIndicator"/>
<short
value="This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)"/>
<definition
value="This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
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<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
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<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
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<code value="Element"/>
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<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
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<type>
<code value="BackboneElement"/>
<profile
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<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
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<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
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<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
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<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
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<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
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<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
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<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
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<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
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<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
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value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
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<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
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<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
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value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
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<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
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value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
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value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
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<type>
<code value="Element"/>
<profile
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<element
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<path
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value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
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value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
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<type>
<code value="Element"/>
<profile
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<element
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value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
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value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
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<code value="Element"/>
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<element
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value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
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<element
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<type>
<code value="BackboneElement"/>
<profile
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<element
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value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
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value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
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<code value="Element"/>
<profile
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<element
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value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
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value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
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<code value="Element"/>
<profile
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<element
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<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
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<profile
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<element
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<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
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<max value="1"/>
<type>
<code value="Element"/>
<profile
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<element
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<path
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<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
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<type>
<code value="BackboneElement"/>
<profile
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<element
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<short
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<definition
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<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance"/>
<short value="9.7.2.4"/>
<definition value="9.7.2.4"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstance"/>
<short
value="When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)"/>
<definition
value="When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup"/>
<short
value="The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)"/>
<definition
value="The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)"/>
<definition
value="The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength"/>
<short value="9.7.2.5"/>
<definition value="9.7.2.5"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength_Presentation"/>
<short
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<definition
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Strength_Concentration"/>
<short
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<definition
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint"/>
<short
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<definition
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.Country"/>
<short
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<definition
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength"/>
<short value="9.7.2.6"/>
<definition value="9.7.2.6"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance"/>
<short
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<definition
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"/>
<short
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<definition
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength"/>
<short
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<definition
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"/>
<short
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<definition
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry"/>
<short
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<definition
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance"/>
<short value="9.7.2.3"/>
<definition value="9.7.2.3"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Substance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Substance"/>
<short
value="A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)"/>
<definition
value="A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength"/>
<short value="9.7.2.5"/>
<definition value="9.7.2.5"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Presentation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.Strength_Presentation"/>
<short
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<definition
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Strength-Concentration">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.Strength_Concentration"/>
<short
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<definition
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.MeasurementPoint"/>
<short
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<definition
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.Country">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.Country"/>
<short
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<definition
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength"/>
<short value="9.7.2.6"/>
<definition value="9.7.2.6"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance"/>
<short
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<definition
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"/>
<short
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<definition
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength"/>
<short
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<definition
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"/>
<short
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<definition
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry"/>
<short
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<definition
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics"/>
<short value="9.6.2.22"/>
<definition value="9.6.2.22"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.CodeSystem">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics.CodeSystem"/>
<short
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<definition
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.OtherCharacteristics.Value">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.OtherCharacteristics.Value"/>
<short
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<definition
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics"/>
<short value="9.6.2.21"/>
<definition value="9.6.2.21"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Height">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Height"/>
<short
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<definition
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Width">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Width"/>
<short
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<definition
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Depth">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Depth"/>
<short
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<definition
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Weight">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Weight"/>
<short
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<definition
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.NominalVolume"/>
<short
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<definition
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.ExternalDiameter"/>
<short
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<definition
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Shape">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Shape"/>
<short
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<definition
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Colour">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Colour"/>
<short
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<definition
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Imprint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Imprint"/>
<short
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<definition
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Image">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Image"/>
<short
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<definition
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ED"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ManufacturedItem.PhysicalCharacteristics.Scoring">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ManufacturedItem.PhysicalCharacteristics.Scoring"/>
<short
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<definition
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
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</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics"/>
<short value="9.6.2.22"/>
<definition value="9.6.2.22"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.CodeSystem">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics.CodeSystem"/>
<short
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<definition
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.OtherCharacteristics.Value">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.OtherCharacteristics.Value"/>
<short
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<definition
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component"/>
<short value="9.6.2.9"/>
<definition value="9.6.2.9"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.ComponentType"/>
<short
value="The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)"/>
<definition
value="The type of component whose material is being described may be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.9.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentMaterial">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.ComponentMaterial"/>
<short
value="The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)"/>
<definition
value="The material(s) of the component can be specified. Materials may be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. (9.6.2.9.3)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.ComponentAlternateMaterial">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.ComponentAlternateMaterial"/>
<short
value="Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)"/>
<definition
value="Alternative materials for the component can be specified. Materials shall be described in accordance with ISO 11238 and its resulting terminology as applicable. A controlled term and a controlled term identifier shall be specified. Alternate material is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of rubber for a stopper). (9.6.2.9.4)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics"/>
<short value="9.6.2.21"/>
<definition value="9.6.2.21"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Height">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Height"/>
<short
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<definition
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Width">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Width"/>
<short
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<definition
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Depth">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Depth"/>
<short
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<definition
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Weight">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Weight"/>
<short
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<definition
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.NominalVolume">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.NominalVolume"/>
<short
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<definition
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.ExternalDiameter">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.ExternalDiameter"/>
<short
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<definition
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Shape">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Shape"/>
<short
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<definition
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Colour">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Colour"/>
<short
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<definition
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Imprint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Imprint"/>
<short
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<definition
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Image">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Image"/>
<short
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<definition
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ED"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.Package-Component.PhysicalCharacteristics.Scoring">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.Package_Component.PhysicalCharacteristics.Scoring"/>
<short
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<definition
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics"/>
<short value="9.6.2.21"/>
<definition value="9.6.2.21"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Height">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Height"/>
<short
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<definition
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Width">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Width"/>
<short
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<definition
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Depth">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Depth"/>
<short
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<definition
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Weight">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Weight"/>
<short
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<definition
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.NominalVolume">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.NominalVolume"/>
<short
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<definition
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.ExternalDiameter">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.ExternalDiameter"/>
<short
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<definition
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Shape">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Shape"/>
<short
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<definition
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Colour">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Colour"/>
<short
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<definition
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Imprint">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Imprint"/>
<short
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<definition
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Image">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Image"/>
<short
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<definition
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ED"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.PhysicalCharacteristics.Scoring">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.PhysicalCharacteristics.Scoring"/>
<short
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<definition
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage"/>
<short value="9.6.2.11"/>
<definition value="9.6.2.11"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeType">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.ShelfLifeType"/>
<short
value="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)"/>
<definition
value="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.ShelfLifeTimePeriod">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.ShelfLifeTimePeriod"/>
<short
value="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)"/>
<definition
value="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PackagedMedicinalProduct.PackageItem-Container.ShelfLife-Storage.SpecialPrecautionsForStorage">
<path
value="MedicinalProduct.PackagedMedicinalProduct.PackageItem_Container.ShelfLife-Storage.SpecialPrecautionsForStorage"/>
<short
value="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)"/>
<definition
value="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct">
<path value="MedicinalProduct.PharmaceuticalProduct"/>
<short value="9.8.2.2"/>
<definition value="9.8.2.2"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm">
<path
value="MedicinalProduct.PharmaceuticalProduct.AdministrableDoseForm"/>
<short
value="This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)"/>
<definition
value="This shall describe the administrable dose form in accordance with the regulated product information. This is after it has undergone any necessary reconstitution, where applicable. The administrable dose form shall be specified in accordance with ISO 11239 and ISO / TS 20440 and the resulting terminology. The term and the term identifier shall be specified. In certain instances, the administrable dose form differs from the manufactured dose form when a transformation of the manufactured dose form has been carried out. The manufactured dose forms of two manufactured items are described as “powder for solution for injection” and “solvent for solution for injection” which after transformation correspond to the administrable dose form “solution for injection”. (9.8.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.UnitOfPresentation">
<path
value="MedicinalProduct.PharmaceuticalProduct.UnitOfPresentation"/>
<short
value="The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)"/>
<definition
value="The unit of presentation is a qualitative term describing the discrete unit in which a pharmaceutical product is presented to describe strength or quantity in cases where a quantitative unit of measurement is not appropriate. It is a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. For pharmaceutical products whose strength is measured as a quantity of weight or volume, the “unit of presentation” can be specified as the immediate (lowest level) container. For solid dose forms and other items whose strength is described on the basis of the amount in the unit of presentation, and which are counted in integer quantities, the unit for quantity shall be “1 unit” and the unit of presentation shall be the item that is counted, specified as a term and a term identifier as defined in ISO 11239 and ISO / TS 20440 and the resulting terminology. (9.8.2.2.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.Device">
<path value="MedicinalProduct.PharmaceuticalProduct.Device"/>
<short value="9.6.2.12"/>
<definition value="9.6.2.12"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceType">
<path value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceType"/>
<short
value="The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)"/>
<definition
value="The type of device shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceTradeName"/>
<short
value="This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)"/>
<definition
value="This can be used to specify the trade name of the device, where applicable, as text. (9.6.2.12.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceQuantity"/>
<short
value="The quantity of the device present in the pack shall be specified. (9.6.2.12.4)"/>
<definition
value="The quantity of the device present in the pack shall be specified. (9.6.2.12.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceListingNumber"/>
<short
value="This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)"/>
<definition
value="This can be used to specify the listing number of the device, where applicable, in text. (9.6.2.12.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceIdentifier"/>
<short
value="A unique device identifier needs to be specified. (9.6.2.12.6)"/>
<definition
value="A unique device identifier needs to be specified. (9.6.2.12.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.Device.ModelNumber">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ModelNumber"/>
<short
value="This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)"/>
<definition
value="This can be used to specify the device model or reference number, where applicable, in text. (9.6.2.12.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.SterilityIndicator"/>
<short
value="Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)"/>
<definition
value="Where applicable, this can be used to specify whether the device is supplied as sterile using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.8)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.SterilisationRequirementIndicator"/>
<short
value="Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)"/>
<definition
value="Where applicable, this can be used to specify whether the device shall be sterilised before use based on an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.12.9)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceUsage"/>
<short
value="The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)"/>
<definition
value="The number of times that the device may be used as described in the regulated product information may be specified. (9.6.2.12.10)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier"/>
<short value="9.6.2.15"/>
<definition value="9.6.2.15"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.BatchNumber"/>
<short
value="Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)"/>
<definition
value="Where applicable, the batch number for the device can be specified, in text. (9.6.2.15.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceBatchIdentifier.ExpirationDate"/>
<short
value="Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)"/>
<definition
value="Where applicable, the expiration date for the batch can be specified. (9.6.2.15.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial"/>
<short value="9.6.2.13"/>
<definition value="9.6.2.13"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Substance"/>
<short
value="The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)"/>
<definition
value="The substance that compose the material of the device shall be described in accordance with ISO 11238 as applicable and its resulting terminology. (9.6.2.13.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.Alternate"/>
<short
value="This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)"/>
<definition
value="This flag indicates if the substance represents an alternative material of the device. NOTE Alternate is used when alternative specific material(s) are allowed to be used for the manufacturing of the package (e.g. different types of plastic for a spoon). (9.6.2.13.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceMaterial.AllergenicIndicator"/>
<short
value="This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)"/>
<definition
value="This flag indicates if the substance is a known or suspected allergen. (9.6.2.13.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature"/>
<short value="9.6.2.14"/>
<definition value="9.6.2.14"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.CodeSystem"/>
<short
value="The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)"/>
<definition
value="The device nomenclature system shall be specified using an appropriate identification system. (9.6.2.14.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.DeviceNomenclature.Value"/>
<short
value="The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)"/>
<definition
value="The term for the device from the specified nomenclature system shall be specified. (9.6.2.14.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics"/>
<short value="9.6.2.22"/>
<definition value="9.6.2.22"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.CodeSystem"/>
<short
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<definition
value="The code system that is used to describe the characteristic shall be specified using an appropriate identification system. (9.6.2.22.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.OtherCharacteristics.Value"/>
<short
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<definition
value="The individual value from the characteristics code system that applies shall be specified using a controlled term and a controlled term identifier. (9.6.2.22.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics"/>
<short value="9.6.2.21"/>
<definition value="9.6.2.21"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Height"/>
<short
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<definition
value="Where applicable, the height can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Width"/>
<short
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<definition
value="Where applicable, the width can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Depth"/>
<short
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<definition
value="Where applicable, the depth can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Weight"/>
<short
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<definition
value="Where applicable, the weight can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.NominalVolume"/>
<short
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<definition
value="Where applicable, the nominal volume can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.ExternalDiameter"/>
<short
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<definition
value="Where applicable, the external diameter can be specified using a numerical value and its unit of measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.21.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Shape"/>
<short
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<definition
value="Where applicable, the shape can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.8)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Colour"/>
<short
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<definition
value="Where applicable, the colour can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.9)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Imprint"/>
<short
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<definition
value="Where applicable, the imprint can be specified as text. (9.6.2.21.10)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Image"/>
<short
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<definition
value="Where applicable, the image can be provided. The format of the image attachment shall be specified by regional implementations. (9.6.2.21.11)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ED"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.PhysicalCharacteristics.Scoring"/>
<short
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<definition
value="Where applicable, the scoring can be specified. An appropriate controlled vocabulary shall be used. The term and the term identifier shall be used. (9.6.2.21.12)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage"/>
<short value="9.6.2.11"/>
<definition value="9.6.2.11"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeType"/>
<short
value="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)"/>
<definition
value="This describes the shelf life, taking into account various scenarios such as shelf life of the Packaged Medicinal Product itself, shelf life after transformation, where necessary, and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.ShelfLifeTimePeriod"/>
<short
value="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)"/>
<definition
value="The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement. The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology. The symbol and the symbol identifier shall be used. (9.6.2.11.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PQ"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage">
<path
value="MedicinalProduct.PharmaceuticalProduct.Device.ShelfLife-Storage.SpecialPrecautionsForStorage"/>
<short
value="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)"/>
<definition
value="Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.6.2.11.4)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.Ingredient">
<path value="MedicinalProduct.PharmaceuticalProduct.Ingredient"/>
<short value="9.7.2.2"/>
<definition value="9.7.2.2"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.IngredientRole"/>
<short
value="The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)"/>
<definition
value="The role of the ingredient as part of the manufactured item/pharmaceutical product shall be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.7.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.AllergenicIndicator"/>
<short
value="This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)"/>
<definition
value="This flag indicates if the ingredient is a known or suspected allergen. (9.7.2.2.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/BL"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation"/>
<short value="9.5.2.2"/>
<definition value="9.5.2.2"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Address">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.Role">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation"/>
<short value="9.5.2.3"/>
<definition value="9.5.2.3"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.OperationType">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.OperationType"/>
<short
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<definition
value="The type of manufacturing operation shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.5.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ManufacturingAuthorisationReferenceNumber"/>
<short
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<definition
value="The reference number of the authorisation for manufacturing or equivalent can be specified in text. (9.5.2.3.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.EffectiveDate">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.EffectiveDate"/>
<short
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<definition
value="The effective date of the manufacturing authorisation stated in the attribute above can be specified. The complete date consisting of day, month and year shall be specified using the ISO 8601 date format. (9.5.2.3.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/DT"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.ConfidentialityIndicator"/>
<short
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<definition
value="The level of confidentiality of the manufacturing operation can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.5.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation"/>
<short value="9.3.2.5"/>
<definition value="9.3.2.5"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Identifier"/>
<short
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<definition
value="The unique identifier of the organisation shall be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Name"/>
<short
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<definition
value="The name of the organisation shall be provided in text. (9.4.2.2.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Address">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Address"/>
<short
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<definition
value="The address of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.2.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<definition
value="The confidentiality level of the organisation information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.2.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.2.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact"/>
<short value="9.4.2.4"/>
<definition value="9.4.2.4"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Name">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Name"/>
<short
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<definition
value="The name of the contact person shall be provided using a standardised structured person name description format. The format will be specified in regional implementation guides. (9.4.2.4.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/PN"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Telecom">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Telecom"/>
<short
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<definition
value="The telecom information (telephone, e-mail, etc.) of the contact person shall be provided using a standardised structured telecoms description format. The format is specified in ISO / TS 20443 . (9.4.2.4.3)"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/TEL"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.Role">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.Role"/>
<short
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<definition
value="The role of the contact person within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.4.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.Contact.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.Contact.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<definition
value="The confidentiality level of the contact person’s information can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be specified. (9.4.2.4.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations"/>
<short value="9.4.2.3"/>
<definition value="9.4.2.3"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationName">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationName"/>
<short
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<definition
value="This is to identify uniquely a location linked to a specific organisation. (9.4.2.3.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationAddress">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationAddress"/>
<short
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<definition
value="The address of the location of the organisation shall be provided using a standardised structured address format. The format is specified in ISO / TS 20443 . (9.4.2.3.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/AD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.LocationRole">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.LocationRole"/>
<short
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<definition
value="The role of the location within the organisation in the context of the Medicinal Product being described shall be specified using a suitable controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.4.2.3.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.Identifier">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.Identifier"/>
<short
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<definition
value="The unique identifier of the location can be provided. An international coding system for unique organisation identifiers can be used. (9.4.2.3.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment-Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency-Organisation.OtherLocations.GeographicCoordinates">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Manufacturer-Establishment_Organisation.Manufacturing-BusinessOperation.MedicinesRegulatoryAgency_Organisation.OtherLocations.GeographicCoordinates"/>
<short
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<definition
value="These are coordinates that identify precisely the location where the organisation is set. See ISO / TS 20443 for more information and example. (9.4.2.3.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance"/>
<short value="9.7.2.4"/>
<definition value="9.7.2.4"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstance"/>
<short
value="When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)"/>
<definition
value="When a specified substance is described, it shall be presented in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.4.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.SpecifiedSubstanceGroup"/>
<short
value="The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)"/>
<definition
value="The group to which a specified substance is assigned in accordance with ISO 11238 and ISO / TS 19844 and its resulting terminology can be used. A term and a term identifier shall be used. (9.7.2.4.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.ConfidentialityIndicator"/>
<short
value="The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)"/>
<definition
value="The confidentiality level of the specified substance information described for the ingredient can be specified using an appropriate controlled vocabulary. The controlled term and a term identifier shall be used. (9.7.2.4.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength"/>
<short value="9.7.2.5"/>
<definition value="9.7.2.5"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Presentation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength_Presentation"/>
<short
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<definition
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength-Concentration">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Strength_Concentration"/>
<short
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<definition
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.MeasurementPoint"/>
<short
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<definition
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.Country"/>
<short
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<definition
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength"/>
<short value="9.7.2.6"/>
<definition value="9.7.2.6"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSubstance"/>
<short
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<definition
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"/>
<short
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<definition
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrength"/>
<short
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<definition
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"/>
<short
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<definition
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.SpecifiedSubstance.Strength.ReferenceStrength.ReferenceStrengthCountry"/>
<short
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<definition
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance"/>
<short value="9.7.2.3"/>
<definition value="9.7.2.3"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Substance"/>
<short
value="A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)"/>
<definition
value="A substance can be specified for an ingredient in the role described. The substance shall be described in accordance with ISO 11238 and ISO / TS 198 44 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.3.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength"/>
<short value="9.7.2.5"/>
<definition value="9.7.2.5"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Presentation">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength_Presentation"/>
<short
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<definition
value="The strength (presentation) shall be specified. It is defined as the quantity or range of quantities of the substance/specified substance present in the unit of presentation of or in the volume (or mass) of the single pharmaceutical product or manufactured item. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and ISO / TS 20440 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength-Concentration">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Strength_Concentration"/>
<short
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<definition
value="The strength (concentration) can be specified. It is defined as a quantity or range of quantities of the substance/specified substance present per unitary volume (or mass). This attribute is only required when the strength (presentation) attribute is valued with the denominator as a non-unitary amount. For solid dose forms, strength (concentration) is generally the same as strength (presentation) and therefore is not required to be expressed separately; the strength (presentation) only is required. When required for expression of strength, the unit of presentation shall be specified in accordance with ISO 11239 and its resulting terminology. The controlled term and a term identifier for the unit of presentation shall be specified in the associated manufactured item or pharmaceutical product. For strength expressed using standard units, the unit of measure symbol and the symbol identifier as defined in ISO 11240 and its resulting controlled vocabulary shall be specified. (9.7.2.5.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.MeasurementPoint"/>
<short
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<definition
value="There are Medicinal Products in jurisdictions where strength is measured at a particular point (for example, the strength of the ingredient in some inhalers is measured at a particular distance from the point of aerosolisation). In these instances, the measurement point can be described using text, as applicable. (9.7.2.5.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.Country"/>
<short
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<definition
value="The country or countries for which the strength range (presentation) and (concentration) and associated measurement point are valid can be specified using values from the ISO 3166 - 1 alpha-2 codes. If a measurement point is specified, one or more countries shall be described as applicable. (9.7.2.5.5)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength"/>
<short value="9.7.2.6"/>
<definition value="9.7.2.6"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSubstance"/>
<short
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<definition
value="If a reference strength substance needs to be specified based on the regulated product information, it shall be described in accordance with ISO 11238 and its controlled vocabulary. A controlled term and a controlled term identifier shall be used. In case of active substances a reference substance shall be specified. (9.7.2.6.2)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceSpecifiedSubstance"/>
<short
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<definition
value="If a reference strength specified substance needs to be described based on the regulated product information, it shall be described in accordance with ISO 11238 and its resulting terminology. A term and a term identifier shall be used. (9.7.2.6.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrength"/>
<short
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<definition
value="The reference strength shall be specified. A numerator value and numerator unit, as well as a denominator value and denominator unit shall be specified. The reference strength can be expressed in two ways: strength (presentation) and strength (concentration). (9.7.2.6.4)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/RTO"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthMeasurementPoint"/>
<short
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<definition
value="The reference strength measurement point, if applicable, can be described as in 9.7.2.5.4 . (9.7.2.6.5)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry">
<path
value="MedicinalProduct.PharmaceuticalProduct.Ingredient.Substance.Strength.ReferenceStrength.ReferenceStrengthCountry"/>
<short
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<definition
value="Where a reference strength country is applicable, it shall be specified based on ISO 3166 - 1 alpha-2 code elements. See 9.7.2.5.4 (9.7.2.6.6)"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics">
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics"/>
<short value="9.8.2.4"/>
<definition value="9.8.2.4"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem">
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.CodeSystem"/>
<short
value="The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)"/>
<definition
value="The code system being used to describe the type of characteristic shall be specified using an appropriate identification system. (9.8.2.4.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value">
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Value"/>
<short
value="The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)"/>
<definition
value="The individual value from the code system that describes the actual characteristic shall be specified using a controlled term and a controlled term identifier. (9.8.2.4.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status">
<path
value="MedicinalProduct.PharmaceuticalProduct.PharmaceuticalProductCharacteristics.Status"/>
<short
value="The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)"/>
<definition
value="The status of the pharmaceutical product characteristic should be listed here, e.g. assigned, not assigned or pending. (9.8.2.4.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.PharmaceuticalProduct.PhPIDSet">
<path value="MedicinalProduct.PharmaceuticalProduct.PhPIDSet"/>
<short value="9.8.2.6"/>
<definition value="9.8.2.6"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets">
<path
value="MedicinalProduct.PharmaceuticalProduct.PhPIDSet.PhPIDIdentifierSets"/>
<short
value="This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)"/>
<definition
value="This class shall carry the relevant identifiers as defined by ISO 11616 and ISO / TS 20451 . This provides a uniform representation of the pharmaceutical product using the substance(s)/specified substance(s), their (reference) strength(s), the administrable dose form and, where applicable, the integral device. (9.8.2.6.0)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration">
<path
value="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration"/>
<short value="9.8.2.3"/>
<definition value="9.8.2.3"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.RouteOfAdministration">
<path
value="MedicinalProduct.PharmaceuticalProduct.RouteOfAdministration.RouteOfAdministration"/>
<short
value="The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0)"/>
<definition
value="The route of administration is a concept that is used to describe the path by which the pharmaceutical product is taken into or makes contact with the body. The route of administration shall be specified using terms and a term identifier as defined in ISO 1 1239 and ISO / TS 20440 and its resulting terminology. (9.8.2.3.0)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.ProductClassification">
<path value="MedicinalProduct.ProductClassification"/>
<short value="9.2.2.4"/>
<definition value="9.2.2.4"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element id="MedicinalProduct.ProductClassification.CodeSystem">
<path value="MedicinalProduct.ProductClassification.CodeSystem"/>
<short
value="The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)"/>
<definition
value="The Medicinal Product can be classified according to various classification systems, which may be regional, jurisdictional or international. The various classifications of the product can be specified in this subclause. The classification system shall be specified using an appropriate identification system; the controlled term and the controlled term identifier shall be specified. (9.2.2.4.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.ProductClassification.Value">
<path value="MedicinalProduct.ProductClassification.Value"/>
<short
value="The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)"/>
<definition
value="The individual value from the classification system that applies to the Medicinal Product shall be specified using a controlled term and a controlled term identifier. (9.2.2.4.3)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.ProductCross-Reference">
<path value="MedicinalProduct.ProductCross-Reference"/>
<short value="9.2.2.7"/>
<definition value="9.2.2.7"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element
id="MedicinalProduct.ProductCross-Reference.I-MPIDCross-Reference">
<path
value="MedicinalProduct.ProductCross-Reference.I_MPIDCross-Reference"/>
<short
value="This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)"/>
<definition
value="This is an attribute used to reference other IMPID(s) or MPID(s) related to the medicinal. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/II"/>
</type>
</element>
<element
id="MedicinalProduct.ProductCross-Reference.ReferencedProductType">
<path
value="MedicinalProduct.ProductCross-Reference.ReferencedProductType"/>
<short
value="This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)"/>
<definition
value="This attribute is to identify which kind of Medicinal Product is cross-referenced. See more information and examples on the use of this attribute in ISO / TS 20443 . (9.2.2.7.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.TherapeuticIndication">
<path value="MedicinalProduct.TherapeuticIndication"/>
<short value="9.9.2.2"/>
<definition value="9.9.2.2"/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/Class"/>
</type>
</element>
<element id="MedicinalProduct.TherapeuticIndication.IndicationText">
<path value="MedicinalProduct.TherapeuticIndication.IndicationText"/>
<short
value="The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)"/>
<definition
value="The authorised therapeutic indication(s) shall be described in text. (9.9.2.2.2)"/>
<min value="1"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/ST"/>
</type>
</element>
<element
id="MedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure">
<path
value="MedicinalProduct.TherapeuticIndication.IndicationAsDisease-Symptom-Procedure"/>
<short
value="The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)"/>
<definition
value="The underlying disease, symptom or procedure that is the indication for treatment can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.3)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.TherapeuticIndication.DiseaseStatus">
<path value="MedicinalProduct.TherapeuticIndication.DiseaseStatus"/>
<short
value="The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)"/>
<definition
value="The status of the disease or symptom of the indication can be specified as it is referenced in the regulated product information using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified. (9.9.2.2.4)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element id="MedicinalProduct.TherapeuticIndication.Comorbidity">
<path value="MedicinalProduct.TherapeuticIndication.Comorbidity"/>
<short
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<definition
value="The race of the specific population for an indication or a contraindication in accordance with the regulated product information can be specified using an appropriate controlled terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.6)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
<element
id="MedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition">
<path
value="MedicinalProduct.UndesirableEffects.PopulationSpecifics.PhysiologicalCondition"/>
<short
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<definition
value="Various aspects of the physiological conditions of the specific population for an indication or contraindication in accordance with the regulated product information can be specified using an appropriate controlled reference terminology. The controlled term and the controlled term identifier shall be specified. (9.9.2.5.7)"/>
<min value="0"/>
<max value="1"/>
<type>
<code value="Element"/>
<profile
value="http://example.com/fhir/example/StructureDefinition/CD"/>
</type>
</element>
</differential>
</StructureDefinition>
IG © 2021+ My Organization. Package my-ig#1.0.0 based on FHIR 4.0.1. Generated 2023-10-31
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